Why Almost Everything You Hear About Medicine Is Wrong
by Sharon Begley, Newsweek, January 24, 2011
"If you follow the news about health research, you risk whiplash. First garlic lowers bad cholesterol, then—after more study—it doesn’t. Hormone replacement reduces the risk of heart disease in postmenopausal women, until a huge study finds that it doesn’t (and that it raises the risk of breast cancer to boot). Eating a big breakfast cuts your total daily calories, or not—as a study released last week finds. Yet even if biomedical research can be a fickle guide, we rely on it.
But what if wrong answers aren’t the exception but the rule? More and more scholars who scrutinize health research are now making that claim. It isn’t just an individual study here and there that’s flawed, they charge. Instead, the very framework of medical investigation may be off-kilter, leading time and again to findings that are at best unproved and at worst dangerously wrong. The result is a system that leads patients and physicians astray—spurring often costly regimens that won’t help and may even harm you.
It’s a disturbing view, with huge implications for doctors, policymakers, and health-conscious consumers. And one of its foremost advocates, Dr. John P.A. Ioannidis, has just ascended to a new, prominent platform after years of crusading against the baseless health and medical claims. As the new chief of Stanford University’s Prevention Research Center, Ioannidis is cementing his role as one of medicine’s top mythbusters. “People are being hurt and even dying” because of false medical claims, he says: not quackery, but errors in medical research.
This is Ioannidis’s moment. As medical costs hamper the economy and impede deficit-reduction efforts, policymakers and businesses are desperate to cut them without sacrificing sick people. One no-brainer solution is to use and pay for only treatments that work. But if Ioannidis is right, most biomedical studies are wrong.
In just the last two months, two pillars of preventive medicine fell. A major study concluded there’s no good evidence that statins (drugs like Lipitor and Crestor) help people with no history of heart disease. The study, by the Cochrane Collaboration, a global consortium of biomedical experts, was based on an evaluation of 14 individual trials with 34,272 patients. Cost of statins: more than $20 billion per year, of which half may be unnecessary. (Pfizer, which makes Lipitor, responds in part that “managing cardiovascular disease risk factors is complicated”). In November a panel of the Institute of Medicine concluded that having a blood test for vitamin D is pointless: almost everyone has enough D for bone health (20 nanograms per milliliter) without taking supplements or calcium pills. Cost of vitamin D: $425 million per year.
Ioannidis, 45, didn’t set out to slay medical myths. A child prodigy (he was calculating decimals at age 3 and wrote a book of poetry at 8), he graduated first in his class from the University of Athens Medical School, did a residency at Harvard, oversaw AIDS clinical trials at the National Institutes of Health in the mid-1990s, and chaired the department of epidemiology at Greece’s University of Ioannina School of Medicine. But at NIH Ioannidis had an epiphany. “Positive” drug trials, which find that a treatment is effective, and “negative” trials, in which a drug fails, take the same amount of time to conduct. “But negative trials took an extra two to four years to be published,” he noticed. “Negative results sit in a file drawer, or the trial keeps going in hopes the results turn positive.” With billions of dollars on the line, companies are loath to declare a new drug ineffective. As a result of the lag in publishing negative studies, patients receive a treatment that is actually ineffective. That made Ioannidis wonder, how many biomedical studies are wrong?
His answer, in a 2005 paper: “the majority.” From clinical trials of new drugs to cutting-edge genetics, biomedical research is riddled with incorrect findings, he argued. Ioannidis deployed an abstruse mathematical argument to prove this, which some critics have questioned. “I do agree that many claims are far more tenuous than is generally appreciated, but to ‘prove’ that most are false, in all areas of medicine, one needs a different statistical model and more empirical evidence than Ioannidis uses,” says biostatistician Steven Goodman of Johns Hopkins, who worries that the most-research-is-wrong claim “could promote an unhealthy skepticism about medical research, which is being used to fuel anti-science fervor.”
Even a cursory glance at medical journals shows that once heralded studies keep falling by the wayside. Two 1993 studies concluded that vitamin E prevents cardiovascular disease; that claim was overturned by more rigorous experiments, in 1996 and 2000. A 1996 study concluding that estrogen therapy reduces older women’s risk of Alzheimer’s was overturned in 2004. Numerous studies concluding that popular antidepressants work by altering brain chemistry have now been contradicted (the drugs help with mild and moderate depression, when they work at all, through a placebo effect), as has research claiming that early cancer detection (through, say, PSA tests) invariably saves lives. The list goes on...."
Showing posts with label medicine. Show all posts
Showing posts with label medicine. Show all posts
Thursday, January 27, 2011
Tuesday, January 26, 2010
The secret about drugs is that they only work in about half of the people who take them
Making Personalized Medicine Pay - BusinessWeek:
"The dirty little secret about drugs is that they only work in about half of the people who take them. So says an educational nonprofit called the Personalized Medicine Coalition, and many drug executives concede as much. Of the $292 billion spent in the U.S. on prescription drugs in 2008, as much as $145 billion went to medications that didn't help individual patients, said Jerel Davis, project manager at McKinsey, at a recent conference. And billions more are being spent to treat adverse drug reactions and other complications. "When you look at the data, it's shocking," says Dr. Robert S. Epstein, chief medical officer at Medco Health Solutions (MHS), a $51 billion company that manages drug prescriptions for 60 million Americans.
Researchers know how to solve this problem. First, figure out the differences between those patients who respond to a drug and those who don't, then treat only to those who will benefit. But this personalized medicine approach 'has been slower to develop than we thought 10 years ago,' says Richard K. Schatzberg, CEO of Generation Health, a startup that offers targeted medicine services. Lack of enthusiasm in the drug industry is a big reason; companies would lose billions of dollars if only those who actually benefit were to use such blockbuster drugs as antidepressants, arthritis medicines, and cholesterol pills...."
"The dirty little secret about drugs is that they only work in about half of the people who take them. So says an educational nonprofit called the Personalized Medicine Coalition, and many drug executives concede as much. Of the $292 billion spent in the U.S. on prescription drugs in 2008, as much as $145 billion went to medications that didn't help individual patients, said Jerel Davis, project manager at McKinsey, at a recent conference. And billions more are being spent to treat adverse drug reactions and other complications. "When you look at the data, it's shocking," says Dr. Robert S. Epstein, chief medical officer at Medco Health Solutions (MHS), a $51 billion company that manages drug prescriptions for 60 million Americans.
Researchers know how to solve this problem. First, figure out the differences between those patients who respond to a drug and those who don't, then treat only to those who will benefit. But this personalized medicine approach 'has been slower to develop than we thought 10 years ago,' says Richard K. Schatzberg, CEO of Generation Health, a startup that offers targeted medicine services. Lack of enthusiasm in the drug industry is a big reason; companies would lose billions of dollars if only those who actually benefit were to use such blockbuster drugs as antidepressants, arthritis medicines, and cholesterol pills...."
Friday, October 30, 2009
Does the Vaccine Matter?
Does the Vaccine Matter? - The Atlantic (November 2009):
"[S]ome flu experts are challenging the medical orthodoxy and arguing that for those most in need of protection, flu shots and antiviral drugs may provide little to none....
When Lisa Jackson, a physician and senior investigator with the Group Health Research Center, in Seattle, began wondering aloud to colleagues if maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science. “People told me, ‘No good can come of [asking] this,’” she says. “‘Potentially a lot of bad could happen’ for me professionally by raising any criticism that might dissuade people from getting vaccinated, because of course, ‘We know that vaccine works.’ This was the prevailing wisdom.”
The history of flu vaccination suggests other reasons to doubt claims that it dramatically reduces mortality. In 2004, for example, vaccine production fell behind, causing a 40 percent drop in immunization rates. Yet mortality did not rise. In addition, vaccine “mismatches” occurred in 1968 and 1997: in both years, the vaccine that had been produced in the summer protected against one set of viruses, but come winter, a different set was circulating. In effect, nobody was vaccinated. Yet death rates from all causes, including flu and the various illnesses it can exacerbate, did not budge...
The most vocal—and undoubtedly most vexing—critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah....
As with vaccines, the scientific evidence for Tamiflu and Relenza is thin at best. In its general-information section, the CDC’s Web site tells readers that antiviral drugs can “make you feel better faster.” True, but not by much. On average, Tamiflu (which accounts for 85 to 90 percent of the flu antiviral-drug market) cuts the duration of flu symptoms by 24hours in otherwise healthy people. In exchange for a slightly shorter bout of illness, as many as one in five people taking Tamiflu will experience nausea and vomiting. About one in five children will have neuropsychiatric side effects, possibly including anxiety and suicidal behavior....
Why, then, has the federal government stockpiled millions of doses of antivirals, at a cost of several billion dollars? And why are physicians being encouraged to hand out prescriptions to large numbers of people, without sound evidence that the drugs will help? The short answer may be that public-health officials feel they must offer something, and these drugs are the only possible remedies at hand. “I have to agree with the critics the antiviral question is not cut-and-dried,” says Fauci. “But [these drugs are] the best we have.” The CDC’s Nancy Cox also acknowledges that the science is not as sound as she might like, but the government still recommends their use. And as with vaccines, she considers additional randomized placebo-controlled trials of the antiviral drugs to be “unethical” and thus out of the question....
The annals of medicine are littered with treatments and tests that became medical doctrine on the slimmest of evidence, and were then declared sacrosanct and beyond scientific investigation. In the 1980s and ’90s, for example, cancer specialists were convinced that high-dose chemotherapy followed by a bone-marrow transplant was the best hope for women with advanced breast cancer, and many refused to enroll their patients in randomized clinical trials that were designed to test transplants against the standard—and far less toxic—therapy. The trials, they said, were unethical, because they knew transplants worked. When the studies were concluded, in 1999 and 2000, it turned out that bone-marrow transplants were killing patients. Another recent example involves drugs related to the analgesic lidocaine. In the 1970s, doctors noticed that the drugs seemed to make the heart beat rhythmically, and they began prescribing them to patients suffering from irregular heartbeats, assuming that restoring a proper rhythm would reduce the patient’s risk of dying. Prominent cardiologists for years opposed clinical trials of the drugs, saying it would be medical malpractice to withhold them from patients in a control group. The drugs were widely used for two decades, until a government-sponsored study showed in 1989 that patients who were prescribed the medicine were three and a half times as likely to die as those given a placebo....
As it stands, more than 50 percent of health-care workers say they do not intend to get vaccinated for swine flu and don’t routinely get their shots for seasonal flu, in part because many of them doubt the vaccines’ efficacy....
“There’s no worse place to go than the hospital during flu season,” says Majumdar. Those who don’t have the flu are more likely to catch it there, and those who do will spread it around, he says. “But we don’t tell people this.”
"[S]ome flu experts are challenging the medical orthodoxy and arguing that for those most in need of protection, flu shots and antiviral drugs may provide little to none....
When Lisa Jackson, a physician and senior investigator with the Group Health Research Center, in Seattle, began wondering aloud to colleagues if maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science. “People told me, ‘No good can come of [asking] this,’” she says. “‘Potentially a lot of bad could happen’ for me professionally by raising any criticism that might dissuade people from getting vaccinated, because of course, ‘We know that vaccine works.’ This was the prevailing wisdom.”
The history of flu vaccination suggests other reasons to doubt claims that it dramatically reduces mortality. In 2004, for example, vaccine production fell behind, causing a 40 percent drop in immunization rates. Yet mortality did not rise. In addition, vaccine “mismatches” occurred in 1968 and 1997: in both years, the vaccine that had been produced in the summer protected against one set of viruses, but come winter, a different set was circulating. In effect, nobody was vaccinated. Yet death rates from all causes, including flu and the various illnesses it can exacerbate, did not budge...
The most vocal—and undoubtedly most vexing—critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah....
“Tom Jefferson has taken a lot of heat just for saying, ‘Here’s the evidence: it’s not very good,’” says Majumdar. “The reaction has been so dogmatic and even hysterical that you’d think he was advocating stealing babies.” Yet while other flu researchers may not like what Jefferson has to say, they cannot ignore the fact that he knows the flu-vaccine literature better than anyone else on the planet. He leads an international team of researchers who have combed through hundreds of flu-vaccine studies. The vast majority of the studies were deeply flawed, says Jefferson. “Rubbish is not a scientific term, but I think it’s the term that applies.” Only four studies were properly designed to pin down the effectiveness of flu vaccine, he says, and two of those showed that it might be effective in certain groups of patients, such as school-age children with no underlying health issues like asthma. The other two showed equivocal results or no benefit.
Flu researchers have been fooled into thinking vaccine is more effective than the data suggest, in part, says Jefferson, by the imprecision of the statistics....As with vaccines, the scientific evidence for Tamiflu and Relenza is thin at best. In its general-information section, the CDC’s Web site tells readers that antiviral drugs can “make you feel better faster.” True, but not by much. On average, Tamiflu (which accounts for 85 to 90 percent of the flu antiviral-drug market) cuts the duration of flu symptoms by 24hours in otherwise healthy people. In exchange for a slightly shorter bout of illness, as many as one in five people taking Tamiflu will experience nausea and vomiting. About one in five children will have neuropsychiatric side effects, possibly including anxiety and suicidal behavior....
Why, then, has the federal government stockpiled millions of doses of antivirals, at a cost of several billion dollars? And why are physicians being encouraged to hand out prescriptions to large numbers of people, without sound evidence that the drugs will help? The short answer may be that public-health officials feel they must offer something, and these drugs are the only possible remedies at hand. “I have to agree with the critics the antiviral question is not cut-and-dried,” says Fauci. “But [these drugs are] the best we have.” The CDC’s Nancy Cox also acknowledges that the science is not as sound as she might like, but the government still recommends their use. And as with vaccines, she considers additional randomized placebo-controlled trials of the antiviral drugs to be “unethical” and thus out of the question....
The annals of medicine are littered with treatments and tests that became medical doctrine on the slimmest of evidence, and were then declared sacrosanct and beyond scientific investigation. In the 1980s and ’90s, for example, cancer specialists were convinced that high-dose chemotherapy followed by a bone-marrow transplant was the best hope for women with advanced breast cancer, and many refused to enroll their patients in randomized clinical trials that were designed to test transplants against the standard—and far less toxic—therapy. The trials, they said, were unethical, because they knew transplants worked. When the studies were concluded, in 1999 and 2000, it turned out that bone-marrow transplants were killing patients. Another recent example involves drugs related to the analgesic lidocaine. In the 1970s, doctors noticed that the drugs seemed to make the heart beat rhythmically, and they began prescribing them to patients suffering from irregular heartbeats, assuming that restoring a proper rhythm would reduce the patient’s risk of dying. Prominent cardiologists for years opposed clinical trials of the drugs, saying it would be medical malpractice to withhold them from patients in a control group. The drugs were widely used for two decades, until a government-sponsored study showed in 1989 that patients who were prescribed the medicine were three and a half times as likely to die as those given a placebo....
As it stands, more than 50 percent of health-care workers say they do not intend to get vaccinated for swine flu and don’t routinely get their shots for seasonal flu, in part because many of them doubt the vaccines’ efficacy....
“There’s no worse place to go than the hospital during flu season,” says Majumdar. Those who don’t have the flu are more likely to catch it there, and those who do will spread it around, he says. “But we don’t tell people this.”
All of which leaves open the question of what people should do when faced with a decision about whether to get themselves and their families vaccinated. There is little immediate danger from getting a seasonal flu shot, aside from a sore arm and mild flu-like symptoms. The safety of the swine flu vaccine remains to be seen. In the absence of better evidence, vaccines and antivirals must be viewed as only partial and uncertain defenses against the flu. And they may be mere talismans. By being afraid to do the proper studies now, we may be condemning ourselves to using treatments based on illusion and faith rather than sound science."
Tuesday, September 22, 2009
When Doing Nothing Is the Best Medicine
When Doing Nothing Is the Best Medicine - WSJ.com:
"What cures colds, flu, sore throats, sore muscles, headaches, stomach aches, diarrhea, menstrual cramps, hangovers, back pain, jaw pain, tennis elbow, blisters, acne and colic, costs nothing, has no weird side effects and doesn't require a prescription?
"What cures colds, flu, sore throats, sore muscles, headaches, stomach aches, diarrhea, menstrual cramps, hangovers, back pain, jaw pain, tennis elbow, blisters, acne and colic, costs nothing, has no weird side effects and doesn't require a prescription?
Plain old-fashioned time. But it's often the hardest medicine for patients to take.
"Most people's bodies and immune systems are wonderful in terms of handling things—if people can be patient," says Ted Epperly, a family physician in Boise, Idaho, and president of the American Academy of Family Physicians.
"I have a mantra: You can do more for yourself than I can do for you," says Raymond Scalettar, a Washington, D.C., rheumatologist and former chairman of the American Medical Association. But, he says, "some patients are very medicine-oriented, and when you tell them they aren't good candidates for a drug they've heard about on TV, they don't come back."
An estimated one-third to one-half of the $2.2 trillion Americans spend annually on health care in the U.S. is spent on unnecessary tests, treatments and doctor visits. Much of that merely buys time for the body to heal itself.
And while temporary relief from symptoms is nothing to sneeze at, it adds up to a considerable amount of spending: $5.4 billion annually on cough and cold remedies, $2.7 billion on headache remedies and $411 million on chest rubs and other analgesics, according to Nielsen Co. Americans also spend an estimated $1 billion on unnecessary antibiotics that don't even relieve the symptoms of viral infections, and contribute to antibiotic resistance. But some patients are so insistent on getting antibiotics that doctors give in.
"I have colleagues who say, 'You can take this pill and get better in two days, or do nothing and get over it in 48 hours,' " says Dr. Scalettar.
Even H1N1, or swine flu, for all the uproar, almost always resolves in a few days with no treatment. The Centers for Disease Control and Prevention is urging physicians to use Tamiflu, an antiviral medication, sparingly to prevent shortages and avoid antiviral resistance. Only people who are hospitalized or at high risk for complications should get Tamiflu, according to the CDC.
The list of "self limiting" maladies—those that require no outside treatment—range from minor annoyances to what might appear to be more serious musculoskeletal problems. "Muscle aches and pain, minor traumas, sprains and strains typically do not need to be seen by a doctor," says Dr. Epperly, who recommends his organization's Web site, www.FamilyDoctor.org, as a resource to look up symptoms and health concerns. "Nausea, vomiting and diarrhea are typically time-limited. People will start to see improvement in two or three days—just watch that you're not throwing up blood," he says. If so, call your doctor.
Almost all viral infections resolve on their own, unless you have a compromised immune system. As a rule of thumb, Dr. Epperly says, infections in the nose, throat, stomach and upper respiratory tract tend to be viral. Infections elsewhere in the body are likely to be caused by bacteria, and those can get worse without antibiotics. About 80% of urinary-tract infections resolve on their own, for example, but about 20% develop into more serious kidney or blood infections. And even if they don't, the symptoms can be very uncomfortable.
Parents are often extremely eager to "do something" for children who complain of sniffles, stomach aches, scrapes and fevers. Yet kids are generally very resilient, writes Lara Zibners, an emergency pediatrician, in her book, "If Your Kid Eats This Book, Everything Will Still Be Okay." (For a fever, she advises calling the doctor if the patient is a baby younger than three months and has a fever over 100.4 degrees. For kids older than that, other symptoms are more important than the thermometer—especially if a child is listless, irritable, unusually sleepy, refusing to eat or drink, or having trouble breathing.)
Some chronic maladies follow predictable courses, according to many medical experts ,whether or not they are treated.
Colic is almost always gone in four months. Some 70% of acne is gone three to four years after it first appears. "Frozen shoulder"—a painful restriction of the shoulder joint—is typically painful for three to six months and stiff for the next four to six months, and resolves completely after one to three more months. Temporomandibular joint (TMJ) pain tends to go away by itself in 18 months. Sciatica resolves on its own in three weeks in 75% of cases.
For all the misery it causes, 80% to 90% of back pain resolves with only "conservative measures" (which include anti-inflammatory drugs, rest, heat, physical therapy and chiropractic treatments). "Sometimes it take days to weeks, sometimes it takes weeks to months, but pain lasts more than three months in only about 10% of cases," says Michael J. Yaszemski, chief of orthopedic spine surgery at the Mayo Clinic in Rochester, Minn.
Whether to operate even in those remaining cases is controversial, he says. With acute lumbar disc herniation, studies have found that two and five years later, there's little difference between patients who had surgery and those who did not. But surgery can sometimes provide relief faster.
"There are those patients who feel they just can't wait—like Joe Montana," says Dr. Yaszemski of the former San Francisco 49ers quarterback, who made headlines when he returned to playing football just eight weeks after spinal surgery in 1986.
Many patients are relieved to hear that they don't need to take medicine, have a blood test or undergo surgery for what ails them. But some feel embarrassed to have taken the doctor's time or frustrated because they think the doctor isn't taking their situation seriously. ("Much depends on the way you tell them," says Dr. Scalettar. "There are some arrogant doctors.")
And some patients resent paying for a visit when all the doctor provides is reassurance that they'll get better with time. "If a patient says, 'You mean, I'm paying $100 for you to tell me there's nothing wrong?' I say, 'There is something wrong—a virus,' " says Dr. Epperly. " 'But more importantly, I can tell you what's not wrong: it's not meningitis or cancer or a brain tumor or some other life-threatening illness. And if the pain doesn't go away in a few days, please, please tell me, and we'll investigate further.' "
"The longer you've known someone, the easier that conversation is," Dr. Epperly adds.
Indeed, applying what some call "a tincture of time" requires time on the doctor's part as well. Explaining why a medication or CT scan or MRI isn't necessary, or what signs to look for if an ailment isn't getting better, often takes more time than writing a quick prescription.
Of course, there are symptoms that people should never ignore, since they could signal a serious illness or a condition that could get worse, not better, with time. Contact your doctor immediately if you experience any of the following:
- Crushing chest pains—the classic signs of a possible heart attack.
- Sudden numbness or weakness on one side of the body, confusion, trouble speaking or severe headache—which could indicate a stroke.
- Sudden, severe headaches.
- Any major injury, especially involving loss of consciousness.
- Coughing up, throwing up or excreting blood.
- Suicidal or homicidal urges.
- Flashing lights in your vision—which could be a detached retina.
- Inability to breath—which could be a severe allergic reaction.
- Recurrent tooth pain. "You can typically give a tooth ache 24 hours," says Dr. Epperly. "If it's an abscess that would require a root canal, it won't get better by itself."
The bottom line: Don't hesitate to call your doctor if you have persistent pain or a loss of function or anything unusual for you. It's worthwhile to rule out something serious that does need medical attention. But if the doctor says you will get better on your own, that's a powerful prescription itself."
Sunday, December 16, 2007
Medical Guesswork
Medical Guesswork
COVER STORY
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.
Quiz >>
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 entire article at the original source
COVER STORY
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.
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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 entire article at the original source
Drugs companies "inventing diseases to boost their profits"
Drugs companies "inventing diseases to boost their profits"
By Mark Henderson, Science Correspondent, The Times
April 11, 2006
PHARMACEUTICAL companies are systematically creating diseases in order to sell more of their products, turning healthy people into patients and placing many at risk of harm, a special edition of a leading medical journal claims today.
The practice of “diseasemongering” by the drug industry is promoting non-existent illnesses or exaggerating minor ones for the sake of profits, according to a set of essays published by the open-access journal Public Library of Science Medicine.
The special issue, edited by David Henry, of Newcastle University in Australia, and Ray Moynihan, an Australian journalist, reports that conditions such as female sexual dysfunction, attention deficit hyperactivity disorder (ADHD) and “restless legs syndrome” have been promoted by companies hoping to sell more of their drugs.
Other minor problems that are a normal part of life, such as symptoms of the menopause, are also becoming increasingly “medicalised”, while risk factors such as high cholesterol levels or osteoporosis are being presented as diseases in their own right, according to the editors.
“Disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm,” they say. “Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.”
Doctors, patients and support groups need to be more aware that pharmaceutical companies are taking this approach, and more research is needed into the changing ways in which conditions are presented, according to the writers.
Disease-awareness campaigns are often funded by drug companies, and “more often designed to sell drugs than to illuminate or inform or educate about the prevention of illness or the maintenance of health”, they say.
Particular conditions that are highlighted in the journal include sexual function in both men and women. The prevalence of female sexual dysfunction, one paper claims, has been highly exaggerated to provide a new market for drugs, while the makers of anti-impotence medicines, such as Viagra and Cialis, have been involved with their presentation as lifestyle drugs that can boost the sexual prowess of healthy men.
Ordinary shyness is routinely presented as a social anxiety disorder and treated with antidepressants, while newly identified conditions such as “restless legs syndrome” — a constant urge to move one’s legs — are presented as being much more common than they really are.
Richard Ley, of the Association of the British Pharmaceutical Industry, rejected the accusations, pointing out that Britain has firm safeguards against disease-mongering. Many of the authors’ criticisms, he said, were aimed squarely at countries such as the United States, where pharmaceuticals can be openly advertised directly to patients.
“Drug companies are not allowed to communicate directly with patients, and we do not invent diseases,” he said.
“We provide information that there are treatments out there that might help certain conditions, but at the end of the day it is down to health professionals to decide if they are appropriate.
“The best safeguard is that the doctor who knows the product and knows the patient’s history is the one who decides what to prescribe.”
TRICK OR TREAT?
MENOPAUSE
Symptoms include hot flushes, night sweats and loss of libido
Criticism too often “medicalised” as part of a “disorder” when it is a normal phase of life
IRRITABLE BOWEL SYNDROME
Symptoms include constipation, cramps and diarrhoea
Criticism promoted by drug companies as a serious illness needing therapy, when it is usually a mild problem
SEXUAL DYSFUNCTION
Symptoms impotence in men, lack of libido or difficulty becoming aroused in women
Criticism drugs such as Viagra marketed not only for treating genuine erectile dysfunction caused by medical problems but as lifestyle improvers
OSTEOPOROSIS
Symptoms thinning of the bones, particularly among postmenopausal women
Criticism portrayed as a disease in its own right, when it is really a risk factor for broken bones
RESTLESS LEGS
Symptoms urge to move legs because of unpleasant feelings, often at night
Criticism prevalence of a relatively rare condition exaggerated by the media, along with the need for treatment
Read entire article at the original source
By Mark Henderson, Science Correspondent, The Times
April 11, 2006
PHARMACEUTICAL companies are systematically creating diseases in order to sell more of their products, turning healthy people into patients and placing many at risk of harm, a special edition of a leading medical journal claims today.
The practice of “diseasemongering” by the drug industry is promoting non-existent illnesses or exaggerating minor ones for the sake of profits, according to a set of essays published by the open-access journal Public Library of Science Medicine.
The special issue, edited by David Henry, of Newcastle University in Australia, and Ray Moynihan, an Australian journalist, reports that conditions such as female sexual dysfunction, attention deficit hyperactivity disorder (ADHD) and “restless legs syndrome” have been promoted by companies hoping to sell more of their drugs.
Other minor problems that are a normal part of life, such as symptoms of the menopause, are also becoming increasingly “medicalised”, while risk factors such as high cholesterol levels or osteoporosis are being presented as diseases in their own right, according to the editors.
“Disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm,” they say. “Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.”
Doctors, patients and support groups need to be more aware that pharmaceutical companies are taking this approach, and more research is needed into the changing ways in which conditions are presented, according to the writers.
Disease-awareness campaigns are often funded by drug companies, and “more often designed to sell drugs than to illuminate or inform or educate about the prevention of illness or the maintenance of health”, they say.
Particular conditions that are highlighted in the journal include sexual function in both men and women. The prevalence of female sexual dysfunction, one paper claims, has been highly exaggerated to provide a new market for drugs, while the makers of anti-impotence medicines, such as Viagra and Cialis, have been involved with their presentation as lifestyle drugs that can boost the sexual prowess of healthy men.
Ordinary shyness is routinely presented as a social anxiety disorder and treated with antidepressants, while newly identified conditions such as “restless legs syndrome” — a constant urge to move one’s legs — are presented as being much more common than they really are.
Richard Ley, of the Association of the British Pharmaceutical Industry, rejected the accusations, pointing out that Britain has firm safeguards against disease-mongering. Many of the authors’ criticisms, he said, were aimed squarely at countries such as the United States, where pharmaceuticals can be openly advertised directly to patients.
“Drug companies are not allowed to communicate directly with patients, and we do not invent diseases,” he said.
“We provide information that there are treatments out there that might help certain conditions, but at the end of the day it is down to health professionals to decide if they are appropriate.
“The best safeguard is that the doctor who knows the product and knows the patient’s history is the one who decides what to prescribe.”
TRICK OR TREAT?
MENOPAUSE
Symptoms include hot flushes, night sweats and loss of libido
Criticism too often “medicalised” as part of a “disorder” when it is a normal phase of life
IRRITABLE BOWEL SYNDROME
Symptoms include constipation, cramps and diarrhoea
Criticism promoted by drug companies as a serious illness needing therapy, when it is usually a mild problem
SEXUAL DYSFUNCTION
Symptoms impotence in men, lack of libido or difficulty becoming aroused in women
Criticism drugs such as Viagra marketed not only for treating genuine erectile dysfunction caused by medical problems but as lifestyle improvers
OSTEOPOROSIS
Symptoms thinning of the bones, particularly among postmenopausal women
Criticism portrayed as a disease in its own right, when it is really a risk factor for broken bones
RESTLESS LEGS
Symptoms urge to move legs because of unpleasant feelings, often at night
Criticism prevalence of a relatively rare condition exaggerated by the media, along with the need for treatment
Read entire article at the original source
Most Cough Medicines Don't Do a Thing -- Here's What Works
Most Cough Medicines Don't Do a Thing -- Here's What Works
By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL
January 10, 2006
Every year consumers spend billions on cough medicines, but a new report from the nation's top chest doctors says many of them don't work.
The finding was issued by the American College of Chest Physicians as part of its comprehensive guidelines for dealing with various forms of cough. The doctors group reviewed numerous medical studies evaluating cough preparations and concluded that many of the key ingredients in popular cough and cold medications simply aren't effective in quieting coughs caused by the common cold.
But there was good news as well. The group concluded that the ingredients found in certain older allergy medications and pain relievers are actually far more effective against cough, even though they aren't marketed as cough treatments.
Among other findings, the group concluded that the drug guaifenesin -- an expectorant found in popular brands such as Wyeth's Robitussin and Mucinex from Adams Respiratory Therapeutics in Chester, N.J. -- is ineffective in curbing cough caused by the common cold. The drug is supposed to work by thinning the mucus and making it easier to cough up phlegm. But among four studies evaluating guaifenesin compared with a placebo, two studies showed benefit while two showed no improvement. As a result, the panel concluded there isn't enough evidence to support its use to help cough caused by colds.
The panel also considered two popular cough suppressants, codeine and dextromethorphan, which potentially work by quieting the brain's cough center. Although the drugs may be effective against certain types of coughs -- like those associated with cancer -- these drugs don't work against cough due to colds, says Richard Irwin, professor of medicine at University of Massachusetts Medical School in Worcester, Mass., and editor in chief of the ACCP guidelines. In addition, codeine, even in large doses, hasn't been shown to work on cough due to a common cold, says Dr. Irwin.
Wyeth, the maker of the Robitussin line of cough products, which contain guaifenesin and dextromethorphan, says the group's findings run counter to conclusions by the Food and Drug Administration, which found the ingredients to be both safe and effective during a sweeping review of over-the-counter cough and cold remedies more than a decade ago.
"Robitussin has a long history of being sold, and it has a loyal following of customers," says Francis Sullivan, spokesman for the Wyeth Consumer Healthcare unit in Madison, N.J. "We believe that if the product didn't work these customers wouldn't purchase it."
Dr. Irwin says one explanation for the popularity of cough remedies might be the placebo effect -- which is a positive reaction to an inactive substance that the patient believes will work. In cough studies, the placebo effect has been shown to be as high as 40%.
The Chest panel also concluded that products containing zinc also are ineffective against cough due to colds. The herb echinacea has also been shown to be ineffective against cough.
The panel did conclude that some older antihistamines -- the kind that make you drowsy -- can be effective against cough caused by a cold. The medication in the drugs that makes you sleepy is the same drug that dries up the secretions in the back of the throat that can contribute to cough. The drugs may also act on the brain center to suppress cough, although how they work isn't entirely clear.
Drugs that may help quiet a cough due to cold include diphenhydramine, the active ingredient in Benadryl, dexbrompheniramine, an active ingredient in Drixoral, and chlorpheniramine, the active ingredient in Chlortrimeton.
Drugs like Benadryl and other drowsiness-inducing antihistamines aren't for everyone. The drowsy side effect is a real concern for people who must operate equipment or drive, and men with prostate problems may suffer additional side effects, such as difficulty urinating. "People think all antihistamines are equal, but it's not the case," says Dr. Irwin.
Many newer antihistamines have been altered so as to not make patients drowsy -- a major selling point of the drugs. However, the change that makes them nondrowsy also may render them ineffective against cough, notes Dr. Irwin.
Pain relievers called nonsteroidal anti-inflammatory drugs, such as naproxen, the active ingredient in Aleve, also may help patients with cough caused by cold. In studies naproxen has been shown to decrease the severity and frequency of cough. As a result, doctors believe it's likely similar drugs, such as the ibuprofen found in Advil, might also help relieve cold-related cough. The drugs may cause stomach upset or increase risk for serious gastrointestinal problems. One study has also linked naproxen with a higher risk for heart problems, although the finding remains controversial.
While the guidelines generally dispute the notion that most over-the-counter cough remedies help coughs due to colds, there is some evidence that drugs like dextromethorphan might help other types of coughs, such as those due to bronchitis.
As a result, it's important that patients with a nagging cough seek a doctor's advice on how to best treat it. Patients also should read the label, because different versions of the same brand often contain different active ingredients. "There are medicines that do work for just about all conditions that cause cough," says Dr. Irwin. "I would think people would want to take a medicine that's got a pretty good chance of working."
Read entire article at original source
By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL
January 10, 2006
Every year consumers spend billions on cough medicines, but a new report from the nation's top chest doctors says many of them don't work.
The finding was issued by the American College of Chest Physicians as part of its comprehensive guidelines for dealing with various forms of cough. The doctors group reviewed numerous medical studies evaluating cough preparations and concluded that many of the key ingredients in popular cough and cold medications simply aren't effective in quieting coughs caused by the common cold.
But there was good news as well. The group concluded that the ingredients found in certain older allergy medications and pain relievers are actually far more effective against cough, even though they aren't marketed as cough treatments.
Among other findings, the group concluded that the drug guaifenesin -- an expectorant found in popular brands such as Wyeth's Robitussin and Mucinex from Adams Respiratory Therapeutics in Chester, N.J. -- is ineffective in curbing cough caused by the common cold. The drug is supposed to work by thinning the mucus and making it easier to cough up phlegm. But among four studies evaluating guaifenesin compared with a placebo, two studies showed benefit while two showed no improvement. As a result, the panel concluded there isn't enough evidence to support its use to help cough caused by colds.
The panel also considered two popular cough suppressants, codeine and dextromethorphan, which potentially work by quieting the brain's cough center. Although the drugs may be effective against certain types of coughs -- like those associated with cancer -- these drugs don't work against cough due to colds, says Richard Irwin, professor of medicine at University of Massachusetts Medical School in Worcester, Mass., and editor in chief of the ACCP guidelines. In addition, codeine, even in large doses, hasn't been shown to work on cough due to a common cold, says Dr. Irwin.
Wyeth, the maker of the Robitussin line of cough products, which contain guaifenesin and dextromethorphan, says the group's findings run counter to conclusions by the Food and Drug Administration, which found the ingredients to be both safe and effective during a sweeping review of over-the-counter cough and cold remedies more than a decade ago.
"Robitussin has a long history of being sold, and it has a loyal following of customers," says Francis Sullivan, spokesman for the Wyeth Consumer Healthcare unit in Madison, N.J. "We believe that if the product didn't work these customers wouldn't purchase it."
Dr. Irwin says one explanation for the popularity of cough remedies might be the placebo effect -- which is a positive reaction to an inactive substance that the patient believes will work. In cough studies, the placebo effect has been shown to be as high as 40%.
The Chest panel also concluded that products containing zinc also are ineffective against cough due to colds. The herb echinacea has also been shown to be ineffective against cough.
The panel did conclude that some older antihistamines -- the kind that make you drowsy -- can be effective against cough caused by a cold. The medication in the drugs that makes you sleepy is the same drug that dries up the secretions in the back of the throat that can contribute to cough. The drugs may also act on the brain center to suppress cough, although how they work isn't entirely clear.
Drugs that may help quiet a cough due to cold include diphenhydramine, the active ingredient in Benadryl, dexbrompheniramine, an active ingredient in Drixoral, and chlorpheniramine, the active ingredient in Chlortrimeton.
Drugs like Benadryl and other drowsiness-inducing antihistamines aren't for everyone. The drowsy side effect is a real concern for people who must operate equipment or drive, and men with prostate problems may suffer additional side effects, such as difficulty urinating. "People think all antihistamines are equal, but it's not the case," says Dr. Irwin.
Many newer antihistamines have been altered so as to not make patients drowsy -- a major selling point of the drugs. However, the change that makes them nondrowsy also may render them ineffective against cough, notes Dr. Irwin.
Pain relievers called nonsteroidal anti-inflammatory drugs, such as naproxen, the active ingredient in Aleve, also may help patients with cough caused by cold. In studies naproxen has been shown to decrease the severity and frequency of cough. As a result, doctors believe it's likely similar drugs, such as the ibuprofen found in Advil, might also help relieve cold-related cough. The drugs may cause stomach upset or increase risk for serious gastrointestinal problems. One study has also linked naproxen with a higher risk for heart problems, although the finding remains controversial.
While the guidelines generally dispute the notion that most over-the-counter cough remedies help coughs due to colds, there is some evidence that drugs like dextromethorphan might help other types of coughs, such as those due to bronchitis.
As a result, it's important that patients with a nagging cough seek a doctor's advice on how to best treat it. Patients also should read the label, because different versions of the same brand often contain different active ingredients. "There are medicines that do work for just about all conditions that cause cough," says Dr. Irwin. "I would think people would want to take a medicine that's got a pretty good chance of working."
Read entire article at original source
Sunday, August 26, 2007
FDA Warns Against Giving Cough Medicine to Toddlers
FDA Warns Against Giving Cough Medicine to Toddlers
The Washington Post
By Rob Stein, Washington Post Staff Writer
Thursday, August 16, 2007; A02
The Food and Drug Administration, concerned about the number of children being accidentally overdosed on over-the-counter cough and cold medicines, yesterday warned parents never to give children younger than age 2 such products without a doctor's approval.
The warning came as the agency announced plans to convene a panel of experts Oct. 18 to review the use of popular cold medicines in children because of mounting concerns about whether the remedies are being used safely.
The FDA began investigating the issue after public health authorities raised questions about the products, citing reports of hundreds of overdoses that resulted in a handful of deaths. Doctors petitioned the FDA in March to review the situation.
"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the agency said in an advisory.
The FDA's decision was welcomed by those concerned about the medications.
"The fact that they are doing this is illustrative that this is a real problem that is on their radar screen," said Baltimore Health Commissioner Joshua M. Sharfstein, who was among those petitioning the agency.
Sharfstein noted that over-the-counter cold and cough medications have never been proven to be effective in children, and parents can easily inadvertently administer the medications in doses that can cause heart problems and other dangerous side effects.
"There's no good evidence of the efficacy of these products, and there are significant safety concerns about their misuse," he said.
Current labels already warn parents not to use the medications on children younger than age 2, indicating that stronger action is needed, such are possibly barring direct marketing of the products for use in young children, Sharfstein said.
Read article at original source
The Washington Post
By Rob Stein, Washington Post Staff Writer
Thursday, August 16, 2007; A02
The Food and Drug Administration, concerned about the number of children being accidentally overdosed on over-the-counter cough and cold medicines, yesterday warned parents never to give children younger than age 2 such products without a doctor's approval.
The warning came as the agency announced plans to convene a panel of experts Oct. 18 to review the use of popular cold medicines in children because of mounting concerns about whether the remedies are being used safely.
The FDA began investigating the issue after public health authorities raised questions about the products, citing reports of hundreds of overdoses that resulted in a handful of deaths. Doctors petitioned the FDA in March to review the situation.
"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the agency said in an advisory.
The FDA's decision was welcomed by those concerned about the medications.
"The fact that they are doing this is illustrative that this is a real problem that is on their radar screen," said Baltimore Health Commissioner Joshua M. Sharfstein, who was among those petitioning the agency.
Sharfstein noted that over-the-counter cold and cough medications have never been proven to be effective in children, and parents can easily inadvertently administer the medications in doses that can cause heart problems and other dangerous side effects.
"There's no good evidence of the efficacy of these products, and there are significant safety concerns about their misuse," he said.
Current labels already warn parents not to use the medications on children younger than age 2, indicating that stronger action is needed, such are possibly barring direct marketing of the products for use in young children, Sharfstein said.
Read article at original source
These Drugs Are for Colds, Not Fidgets
These Drugs Are for Colds, Not Fidgets
By Leslie Berger, The New York Times, August 14, 2007
In a society that savors convenience, parents are sometimes tempted (or pressured) to use over-the-counter cold and allergy drugs to get their children to sleep. In a widely reported incident last month, a Georgia woman and her talkative 19-month-old son were removed from a flight to Oklahoma after the toddler kept repeating, “Bye-bye, plane!” during the safety demonstration, the annoyed flight attendant suggested a dose of Benadryl, and the mother took offense.
Whatever the merits of that confrontation, doctors say there is one lesson to take away: drugs like Benadryl should never be given to sedate a child. For one thing, they can have side effects, including constipation and respiratory problems. And for another, in some children they produce the exact opposite of the desired effect.
“Instead of becoming sleepy they can become very animated and less controllable,” said Dr. Charles J. Coté, a pediatric anesthesiologist at Harvard Medical School.
That paradoxical reaction to the antihistamines contained in many common cold medicines and allergy remedies occurs in as many as 5 percent to 10 percent of children, some experts say. It is not medically dangerous, but it can take a couple of hours to wear off. Indeed, the fine print on these drugs’ labels warns of possible “excitability.”
Nevertheless, the use of such medicines to make children drowsy is widespread. “Inappropriate use clearly is a very common practice,” said Dr. Philip Walson, a professor of pediatrics and pharmacology at Cincinnati Children’s Hospital Medical Center.
Dr. Philippe Similon, a pediatrician in Manhattan, says the question of how to travel with young children, and whether it is safe to give them nonprescription sedatives, has become one of the most common in his practice.
He advises against it, instead suggesting behavioral techniques. “Make sure they are well rested before they get on the plane,” he said, “that they’ve eaten well and that they have something to distract them like a small toy or a book.”
Dr. Coté and other experts say that while children under 2 tend to have the hardest time staying put in a confined space, they are also the most vulnerable to overdoses and respiratory problems. If a sleeping child’s airways become blocked — by a nose pressed against a seat, for example — the sedation can blunt the natural reflex to shift position.
“There are no real safe sedatives to give children just sort of over-the-counter,” Dr. Walson said. “Sedation is a big deal.”
Dr. Walson was an expert witness in the 2005 trial of a Montana day care operator who was convicted of negligent homicide in the death of a 1-year-old in her care. The jury found she had given children an over-the-counter allergy medicine to get them to nap. “It turned out she’d been buying quarts of it, literally, and giving it to all the babies,” Dr. Walson said.
Most popular allergy and cold medicines were not developed as sedatives; the recommended doses on their labels are meant for their intended use.
Moreover, the Food and Drug Administration has begun a long-sought review of popular nonprescription cough and cold medicines marketed for children as young as 2, in response to concerns that they have caused several serious health problems. The drugs, which include Toddler’s Dimetapp, Triaminic Infant and Little Colds, were approved for sale years before the F.D.A. began requiring rigorous premarket testing, and they were never adequately tested in children.
Diphenhydramine, the main compound in Benadryl, also predates current drug agency standards and was never tested in children, but it is lower on the review’s list of priorities, said Dr. Wayne Snodgrass, a professor of pediatrics, pharmacology and toxicology at the University of Texas Medical Branch at Galveston and chairman of the committee on drugs for the American Academy of Pediatrics.
McNeil Consumer Healthcare, which makes Benadryl, said in a statement that the drug was intended to relieve the symptoms of allergies and colds, and added, “We do not recommend nor condone the use of any of our products for purposes other than those indicated on the label.”
Dr. Kenneth R. Cohen, a psychiatrist in New York who specializes in psychopharmacology, suggested another way of looking at the problem: not the restless children, but the adults who have a hard time dealing with them.
For those adults, he said, there are anti-anxiety medications, which should be taken under a doctor’s direction and should be tried out at home first.
“Children absolutely should not be sedated on airplanes for the convenience of other passengers,” Dr. Cohen said.
Read article at original source
By Leslie Berger, The New York Times, August 14, 2007
In a society that savors convenience, parents are sometimes tempted (or pressured) to use over-the-counter cold and allergy drugs to get their children to sleep. In a widely reported incident last month, a Georgia woman and her talkative 19-month-old son were removed from a flight to Oklahoma after the toddler kept repeating, “Bye-bye, plane!” during the safety demonstration, the annoyed flight attendant suggested a dose of Benadryl, and the mother took offense.
Whatever the merits of that confrontation, doctors say there is one lesson to take away: drugs like Benadryl should never be given to sedate a child. For one thing, they can have side effects, including constipation and respiratory problems. And for another, in some children they produce the exact opposite of the desired effect.
“Instead of becoming sleepy they can become very animated and less controllable,” said Dr. Charles J. Coté, a pediatric anesthesiologist at Harvard Medical School.
That paradoxical reaction to the antihistamines contained in many common cold medicines and allergy remedies occurs in as many as 5 percent to 10 percent of children, some experts say. It is not medically dangerous, but it can take a couple of hours to wear off. Indeed, the fine print on these drugs’ labels warns of possible “excitability.”
Nevertheless, the use of such medicines to make children drowsy is widespread. “Inappropriate use clearly is a very common practice,” said Dr. Philip Walson, a professor of pediatrics and pharmacology at Cincinnati Children’s Hospital Medical Center.
Dr. Philippe Similon, a pediatrician in Manhattan, says the question of how to travel with young children, and whether it is safe to give them nonprescription sedatives, has become one of the most common in his practice.
He advises against it, instead suggesting behavioral techniques. “Make sure they are well rested before they get on the plane,” he said, “that they’ve eaten well and that they have something to distract them like a small toy or a book.”
Dr. Coté and other experts say that while children under 2 tend to have the hardest time staying put in a confined space, they are also the most vulnerable to overdoses and respiratory problems. If a sleeping child’s airways become blocked — by a nose pressed against a seat, for example — the sedation can blunt the natural reflex to shift position.
“There are no real safe sedatives to give children just sort of over-the-counter,” Dr. Walson said. “Sedation is a big deal.”
Dr. Walson was an expert witness in the 2005 trial of a Montana day care operator who was convicted of negligent homicide in the death of a 1-year-old in her care. The jury found she had given children an over-the-counter allergy medicine to get them to nap. “It turned out she’d been buying quarts of it, literally, and giving it to all the babies,” Dr. Walson said.
Most popular allergy and cold medicines were not developed as sedatives; the recommended doses on their labels are meant for their intended use.
Moreover, the Food and Drug Administration has begun a long-sought review of popular nonprescription cough and cold medicines marketed for children as young as 2, in response to concerns that they have caused several serious health problems. The drugs, which include Toddler’s Dimetapp, Triaminic Infant and Little Colds, were approved for sale years before the F.D.A. began requiring rigorous premarket testing, and they were never adequately tested in children.
Diphenhydramine, the main compound in Benadryl, also predates current drug agency standards and was never tested in children, but it is lower on the review’s list of priorities, said Dr. Wayne Snodgrass, a professor of pediatrics, pharmacology and toxicology at the University of Texas Medical Branch at Galveston and chairman of the committee on drugs for the American Academy of Pediatrics.
McNeil Consumer Healthcare, which makes Benadryl, said in a statement that the drug was intended to relieve the symptoms of allergies and colds, and added, “We do not recommend nor condone the use of any of our products for purposes other than those indicated on the label.”
Dr. Kenneth R. Cohen, a psychiatrist in New York who specializes in psychopharmacology, suggested another way of looking at the problem: not the restless children, but the adults who have a hard time dealing with them.
For those adults, he said, there are anti-anxiety medications, which should be taken under a doctor’s direction and should be tried out at home first.
“Children absolutely should not be sedated on airplanes for the convenience of other passengers,” Dr. Cohen said.
Read article at original source
Sunday, March 11, 2007
Medication Errors During Surgeries Particularly Dangerous
Medication Errors During Surgeries Particularly Dangerous
By Amanda Gardner, HealthDay Reporter
Washington Post, Tuesday, March 6, 2007
Medication errors that occur during the course of a surgical procedure are three times more likely to harm a patient than errors committed during other types of hospital care, a new report shows.
Some 5 percent of such errors resulted in harm, said Diane Cousins, vice president of the department of Healthcare Quality and Information at the United States Pharmacopeia (USP), which conducted the survey. The nonprofit group sets safety standards for pharmaceutical care that are used worldwide.
The report analyzed 11,000 errors reported by 500 hospitals between 1998 and 2005. This is the largest known analysis of medical errors related to surgery, according to the USP.
Overall, there were about 500 harmful errors, including four fatalities, one of which involved a child.
Errors were most common in the operating room and were most likely to affect children. Almost 13 percent of pediatric errors resulted in harm, proportionately higher than any other group studied.
The most common medication errors in the surgery setting were receiving the wrong drug, the wrong amount of a drug, receiving the drug at the wrong time or not receiving the drug at all. Antibiotics and painkillers were most frequently found to be involved in errors.
The report focused on four parts of the "surgical continuum" -- outpatient surgery, the preoperative holding area, the operating room, and the post-anesthesia care unit.
There were 2,437 reported errors in outpatient surgery, 3.3 percent of them resulting in harm. In the pediatric population, 3.6 percent of errors resulted in harm, vs. 5.1 percent in adults and 5.1 percent in geriatric patients. Problems most commonly involved central nervous system medications and antimicrobials, with central nervous system drugs most likely to result in harm.
In the preoperative holding area, there were 779 errors, with 2.8 percent resulting in harm. For children, 4.2 percent of errors resulted in harm, compared to 7.1 percent for adults and 2.6 percent for elderly patients.
In the operating room, 3,773 errors were reported, 7.3 percent of which resulted in harm. Almost 17 percent of errors resulted in harm in children, 11.3 percent in adults and 10 percent in geriatric patients. Two of the errors caused or contributed to patient deaths.
Finally, in the post-anesthesia care unit, 3,260 errors occurred, of which 5.8 percent resulted in harm. Here, more than 20 percent of errors in children resulted in harm, compared with 8.7 percent in adults and 8.8 percent in elderly patients. Morphine drips and other patient-controlled analgesia machines were often involved in the most harmful errors. Tubing misconnections were also involved, as was an absence of reliable allergy information. Medication errors caused or contributed to two deaths.
Overall, Cousins said, the so-called "surgical continuum" was really a fragmented system in which numerous hand-offs of patients resulted in lack of coordination and errors.
The report included 47 recommendations, more than any other year. These included implementing strategies to improve communication among team members, designating a pharmacist to coordinate medication safety on behalf of a patient, working to ensure that medications are administered on time (particularly antibiotics) and issuing a call to manufacturers to provide ready-to-use sterile packaging, especially for drugs administered to children.
More information
Find out more about the report at USP.
SOURCES: March 6, 2007, teleconference with Diane D. Cousins, R.Ph., vice president, Department of Healthcare Quality and Information, USP;MEDMARX Data Report: A Chartbook of Medication Error Findings from the Perioperative Settings from 1998-2005.
Read article at original source
By Amanda Gardner, HealthDay Reporter
Washington Post, Tuesday, March 6, 2007
Medication errors that occur during the course of a surgical procedure are three times more likely to harm a patient than errors committed during other types of hospital care, a new report shows.
Some 5 percent of such errors resulted in harm, said Diane Cousins, vice president of the department of Healthcare Quality and Information at the United States Pharmacopeia (USP), which conducted the survey. The nonprofit group sets safety standards for pharmaceutical care that are used worldwide.
The report analyzed 11,000 errors reported by 500 hospitals between 1998 and 2005. This is the largest known analysis of medical errors related to surgery, according to the USP.
Overall, there were about 500 harmful errors, including four fatalities, one of which involved a child.
Errors were most common in the operating room and were most likely to affect children. Almost 13 percent of pediatric errors resulted in harm, proportionately higher than any other group studied.
The most common medication errors in the surgery setting were receiving the wrong drug, the wrong amount of a drug, receiving the drug at the wrong time or not receiving the drug at all. Antibiotics and painkillers were most frequently found to be involved in errors.
The report focused on four parts of the "surgical continuum" -- outpatient surgery, the preoperative holding area, the operating room, and the post-anesthesia care unit.
There were 2,437 reported errors in outpatient surgery, 3.3 percent of them resulting in harm. In the pediatric population, 3.6 percent of errors resulted in harm, vs. 5.1 percent in adults and 5.1 percent in geriatric patients. Problems most commonly involved central nervous system medications and antimicrobials, with central nervous system drugs most likely to result in harm.
In the preoperative holding area, there were 779 errors, with 2.8 percent resulting in harm. For children, 4.2 percent of errors resulted in harm, compared to 7.1 percent for adults and 2.6 percent for elderly patients.
In the operating room, 3,773 errors were reported, 7.3 percent of which resulted in harm. Almost 17 percent of errors resulted in harm in children, 11.3 percent in adults and 10 percent in geriatric patients. Two of the errors caused or contributed to patient deaths.
Finally, in the post-anesthesia care unit, 3,260 errors occurred, of which 5.8 percent resulted in harm. Here, more than 20 percent of errors in children resulted in harm, compared with 8.7 percent in adults and 8.8 percent in elderly patients. Morphine drips and other patient-controlled analgesia machines were often involved in the most harmful errors. Tubing misconnections were also involved, as was an absence of reliable allergy information. Medication errors caused or contributed to two deaths.
Overall, Cousins said, the so-called "surgical continuum" was really a fragmented system in which numerous hand-offs of patients resulted in lack of coordination and errors.
The report included 47 recommendations, more than any other year. These included implementing strategies to improve communication among team members, designating a pharmacist to coordinate medication safety on behalf of a patient, working to ensure that medications are administered on time (particularly antibiotics) and issuing a call to manufacturers to provide ready-to-use sterile packaging, especially for drugs administered to children.
More information
Find out more about the report at USP.
SOURCES: March 6, 2007, teleconference with Diane D. Cousins, R.Ph., vice president, Department of Healthcare Quality and Information, USP;MEDMARX Data Report: A Chartbook of Medication Error Findings from the Perioperative Settings from 1998-2005.
Read article at original source
Medication Errors Are Studied
Medication Errors Are Studied
Medication Errors Are Studied
By DONALD G. McNEIL Jr., New York Times, March 7, 2007
Young children are the most likely victims of surgery-related medication mistakes, a new study has found, and poor communication as the patient moves from the operating room to recovery is the most likely culprit.
The study, released yesterday, was done by the United States Pharmacopeia, which sets standards for the pharmaceutical industry, and by the Uniformed Services University of the Health Sciences in Bethesda, Md., and two nurses’ associations.
Medical error has been a charged topic ever since a 1999 report by the Institute of Medicine, “To Err Is Human,” estimated that such mistakes led to as many as 98,000 deaths a year — more than highway accidents and breast cancer combined.
The current study did not try to estimate total error rates. Instead, it analyzed 11,000 mistakes that had been voluntarily and anonymously reported to the pharmacopeia by hundreds of hospitals since 1998.
The study was confined to errors made on patients undergoing surgery, and the rate of harm, 5 percent, was much higher than is typical for medication errors. Among children it was 12 percent.
Most of the errors involved painkillers and antibiotics. Four resulted in deaths, and one death was of a child.
Problems typically arose when a patient was handed off from the preoperative team to the operating room to the recovery room to the regular ward nurses, said Diane Cousins, a health care specialist at the pharmacopeia and one of the authors. “The system is often very fragmented,” Ms. Cousins said.
Typical dangerous mistakes were failures to administer antibiotics before surgery, failures to note allergies, errors in setting pumps that dispense blood thinners or painkillers, and giving overdoses to infants.
In several cases described in the report, poor penmanship, careless listening or bad arithmetic caused patients to get doses 10 or even 50 times as high as they should.
“It’s beyond troubling that the smallest, youngest patients are the ones most at risk,” Ms. Cousins said.
There are 10,000 drugs in the marketplace, she said, and many have never been tested on children in clinical trials, so doses are often made by guesswork based on weight, involving conversion of pounds to kilograms, sometimes by nurses who are not pediatric specialists.
“These may be back-of-the-envelope calculations not checked by anyone,” she said, “and they are often in very tiny amounts — milliliters — and that in itself breeds errors.”
The report made 42 recommendations, among them that hospitals improve communication and designate a pharmacist to be consulted for each patient.
Since 1999, committees investigating medical mistakes have routinely recommended that hospitals install computerized systems for prescribing drugs, which can sound alarms when a toxic combination is ordered for a patient. But fewer than 10 percent of all hospitals have them.
Read article at the original source
Medication Errors Are Studied
By DONALD G. McNEIL Jr., New York Times, March 7, 2007
Young children are the most likely victims of surgery-related medication mistakes, a new study has found, and poor communication as the patient moves from the operating room to recovery is the most likely culprit.
The study, released yesterday, was done by the United States Pharmacopeia, which sets standards for the pharmaceutical industry, and by the Uniformed Services University of the Health Sciences in Bethesda, Md., and two nurses’ associations.
Medical error has been a charged topic ever since a 1999 report by the Institute of Medicine, “To Err Is Human,” estimated that such mistakes led to as many as 98,000 deaths a year — more than highway accidents and breast cancer combined.
The current study did not try to estimate total error rates. Instead, it analyzed 11,000 mistakes that had been voluntarily and anonymously reported to the pharmacopeia by hundreds of hospitals since 1998.
The study was confined to errors made on patients undergoing surgery, and the rate of harm, 5 percent, was much higher than is typical for medication errors. Among children it was 12 percent.
Most of the errors involved painkillers and antibiotics. Four resulted in deaths, and one death was of a child.
Problems typically arose when a patient was handed off from the preoperative team to the operating room to the recovery room to the regular ward nurses, said Diane Cousins, a health care specialist at the pharmacopeia and one of the authors. “The system is often very fragmented,” Ms. Cousins said.
Typical dangerous mistakes were failures to administer antibiotics before surgery, failures to note allergies, errors in setting pumps that dispense blood thinners or painkillers, and giving overdoses to infants.
In several cases described in the report, poor penmanship, careless listening or bad arithmetic caused patients to get doses 10 or even 50 times as high as they should.
“It’s beyond troubling that the smallest, youngest patients are the ones most at risk,” Ms. Cousins said.
There are 10,000 drugs in the marketplace, she said, and many have never been tested on children in clinical trials, so doses are often made by guesswork based on weight, involving conversion of pounds to kilograms, sometimes by nurses who are not pediatric specialists.
“These may be back-of-the-envelope calculations not checked by anyone,” she said, “and they are often in very tiny amounts — milliliters — and that in itself breeds errors.”
The report made 42 recommendations, among them that hospitals improve communication and designate a pharmacist to be consulted for each patient.
Since 1999, committees investigating medical mistakes have routinely recommended that hospitals install computerized systems for prescribing drugs, which can sound alarms when a toxic combination is ordered for a patient. But fewer than 10 percent of all hospitals have them.
Read article at the original source
Thursday, October 19, 2006
When More Medicine Is Less
When More Medicine Is Less
A Dartmouth study finds a greater risk of death among patients treated in high-cost hospitals and clinics -- and highlights conflicts of interest
COVER STORY
By John Carey
BusinessWeek, MAY 29, 2006
Getting more medical care, and paying more for it, can actually make your health worse. That's the paradoxical conclusion of Dartmouth Medical School's Dr. Elliot S. Fisher. He found that the amount spent per person on health care varies dramatically in different parts of the country. Southern California is high cost, for instance, while Northern California is low cost. Spending is high in the Boston area, and low in Western Massachusetts and Minnesota.
Fisher originally expected to find that people in areas with more healthcare would be healthier and longer-lived. The opposite was true. "If anything, it looks like there is a substantially increased risk of death if cared for in high-cost systems," he says. The reason: The additional tests and procedures in the high-cost areas bring more risks than benefits. "A large portion of those extra costs are due just to proximity to health care," says George Bennett, CEO of Health Dialog Analytic Solutions, which tries to get unbiased information to patients. "Not all those expenditures are optimal or even appropriate."
Why does this happen? Clearly, one huge underlying cause is money. The way the U.S. health-care system is structured offers doctors, hospitals, and companies enormous financial incentives to provide more and more care. Surgeons will get paid if they do a bypass operations, insert ear tubes in children, or take out a prostate. If they recommend waiting or doing drug therapy instead, there's no payday.
"You get paid for operating and not paid for not operating," says Dr. Jack Paradise, a professor of pediatrics and otolaryngology at the Pittsburgh School of Medicine and Children's Hospital of Pittsburgh. "Conflict of interest is hard to rule out."
POTENTIAL CONFLICTS. Similarly, hospitals get higher revenues if they put more patients in their new catheter labs or operating rooms. This isn't to say financial considerations outweigh medical choices. But studies have shown wide variations in the amount of care among hospitals -- and again, more care doesn't bring better results.
Researchers at the Center for the Evaluative Clinical Sciences at Dartmouth Medical School have looked in detail at what happens in the last six months of life at 77 top hospitals in the U.S. The results were startling: The average number of days spent in the hospital during the last six months of life was 10.1 days at Stanford University hospital compared to 27.1 days at New York University Medical Center. The average number of doctors visits ranged from 17.6 to 76.2, with NYU at the top.
Yet there's no evidence that the more intensive care brings better outcomes or quality of life. In fact, the researchers suggest, the opposite is true. "The problem is not underuse in low-rate regions and hospitals, but overuse and inefficiency in high-rate regions," concludes Dr. John E. Wennberg, professor of medicine and director of Dartmouth's Center for the Evaluative Clinical Sciences.
The potential conflicts of interest are even starker with drug and medical device makers. The pharmaceutical and device industries are, after all, businesses. Like any businesses, they would be remiss in their duty to shareholders if they didn't try to sell as many of their products as possible.
GOVERNMENT CONCERN. Health care is different from, say, selling cars. No one is hurt if people buy one car over another, or more cars than they need. But for all their benefits, drugs have dangers. Taking the wrong one, or the wrong combination, or too high a dose, or one that's not needed, does hurt people -- and raises health care costs unnecessarily.
That's why the Food & Drug Administration puts curbs on the marketing practices of companies. But because of the huge amounts of money that come with increased sales, they have every incentive to push the envelope when it comes to marketing. As a result, they often work to turn ordinary conditions, like jittery legs, into "diseases" that need treatment (see BW Online, 05/08/06, "Hey, You Don't Look So Good").
They woo doctors with free samples, gifts, trips, and other enticements to prescribe more drugs and use additional devices. A recent lawsuit, for instance, accuses Medtronic (MDT ) of handing hundreds of thousands of dollars for minimal work to prominent back surgeons who are in a position to boost use of the company's spinal-implants. Medtronic spokesman Rob Clark notes that these are allegations. "We do not tolerate any kind of conduct that is unethical...or violate the law," he says.
BOTTOM-LINE BIAS. In another case, Warner-Lambert, a part of Pfizer, (PFE ) was ordered to pay $430 million after pleading guilty to charges of illegally marketing its epilepsy drug, Neurontin, for unapproved uses. The company aggressively pushed the drug for conditions like bipolar disorder, back pain, and headache -- for which there was little or no evidence of effectiveness.
The marketing campaigns, which included trips and big "speaker" fees to doctors, turned the drug into a blockbuster, with billions of dollars in sales per year. But while the practices fattened the company's bottom line, many patients may have been hurt by unnecessary use of the drug, which lawsuits allege can cause suicidal thoughts, tumors, and convulsions.
These powerful financial incentives make it that much harder to get the right treatments and the right amount of care to Americans.
Read article at the original source
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
Medicine's Industrial Revolution
Medicine's Industrial Revolution
COVER STORY
By Howard Gleckman, with John Carey
BusinessWeek, MAY 29, 2006
Sometimes medicine performs just as it should. Vaccines have banished smallpox. Surgery can cure early-stage colon cancer. But the disturbing truth is treatments that are proven to work reach only about half of the Americans who need them, according to a series of studies by RAND Corp. And in hospitals, simple measures that protect patients' lives are often hard to implement.
Hygiene is a good example. For 150 years we have known that doctors with unwashed hands pass infections from patient to patient. The Centers for Disease Control & Prevention figures that 80% of hospital-acquired infections are transmitted this way, costing billions of dollars annually to treat and killing thousands of people.
With this in mind, the University of Pittsburgh Medical Center's Presbyterian Hospital installed alcohol-wash dispensers in every room and allowed nurses to ban doctors who don't wash up from entering patients' rooms. Yet more than one-quarter of UPMC's doctors still haven't gotten the message, says Chief Medical Officer Loren H. Roth. Things have improved in recent years, "but a lot of physicians and residents are still not complying," he says.
One major cause for such huge gaps in care is that financial incentives can be skewed. Insurance companies, which have learned that high infection rates cost them money, are beginning to provide bonuses to encourage hospitals to make big improvements. Highmark Inc., which operates the Blue Cross/Blue Shield plans in Pittsburgh, will give UPMC $10 million this year for lowering infections.
But doctors don't have the same incentives. They are usually not hospital employees and are paid based on the number of patients they see and procedures they do. Repeatedly stopping to wash up may slow them down and cost them money. That has hospitals such as UPMC as well as private insurance companies and Medicare scrambling for new ideas. "How do we align incentives so we pay more for prevention than for solving the disaster after it happens?" asks Donald R. Fischer, chief medical officer at Highmark.
UPMC's Roth says that improving the quality of care may also mean challenging a bedrock belief: that each patient is unique and that doctors must bring individualized judgment to each case. This view "has a kind of appeal to it for both the profession and patients," says Roth, "but it is not so." Most illnesses and injuries can best be treated by standardizing care, he argues. The goal is to "industrialize every process we can."
This idea horrifies some doctors, but businesses and insurance companies, who pay many of the bills, are cheering Roth on. "We know if you take beta blockers, you are much less likely to have a heart attack," explains Helen Darling, president of the Washington-based National Business Group on Health, which represents major employers. "We can reward you for meeting those standards."
Independence Blue Cross has gone a step further. It gives physicians lists of members with chronic conditions such as diabetes and asthma. The list includes the recommended treatments and tells who has received them. "Then when a patient shows up, the missing services can be provided," explains Dr. I. Steven Udvarhelyi, senior vice-president at the insurer. Doctors, who were leery at first, have embraced the plan.
Of course, you have to get people into physicians' offices. To do this, several health plans and companies have teamed up with Health Dialog Analytic Solutions, which identifies employees or plan members with the greatest needs and reaches out through phone calls and mailings. "The touch is very soft," says Joe Checkley, director of global benefits at American Standard Cos (ASD ). "It's saying: 'Here are some tools for you, and what can I do to help?"'
The early results are good. At Independence Blue Cross, with about 2 million members, "we know that the program overall reduces medical costs by about 2%," says Udvarhelyi. "That's for the entire population, not just the people that we touch. For them the reduction is orders of magnitude larger." With efforts like these, treatments that do work are now getting to more of the people who need them.
Read article at the original source
COVER STORY
By Howard Gleckman, with John Carey
BusinessWeek, MAY 29, 2006
Sometimes medicine performs just as it should. Vaccines have banished smallpox. Surgery can cure early-stage colon cancer. But the disturbing truth is treatments that are proven to work reach only about half of the Americans who need them, according to a series of studies by RAND Corp. And in hospitals, simple measures that protect patients' lives are often hard to implement.
Hygiene is a good example. For 150 years we have known that doctors with unwashed hands pass infections from patient to patient. The Centers for Disease Control & Prevention figures that 80% of hospital-acquired infections are transmitted this way, costing billions of dollars annually to treat and killing thousands of people.
With this in mind, the University of Pittsburgh Medical Center's Presbyterian Hospital installed alcohol-wash dispensers in every room and allowed nurses to ban doctors who don't wash up from entering patients' rooms. Yet more than one-quarter of UPMC's doctors still haven't gotten the message, says Chief Medical Officer Loren H. Roth. Things have improved in recent years, "but a lot of physicians and residents are still not complying," he says.
One major cause for such huge gaps in care is that financial incentives can be skewed. Insurance companies, which have learned that high infection rates cost them money, are beginning to provide bonuses to encourage hospitals to make big improvements. Highmark Inc., which operates the Blue Cross/Blue Shield plans in Pittsburgh, will give UPMC $10 million this year for lowering infections.
But doctors don't have the same incentives. They are usually not hospital employees and are paid based on the number of patients they see and procedures they do. Repeatedly stopping to wash up may slow them down and cost them money. That has hospitals such as UPMC as well as private insurance companies and Medicare scrambling for new ideas. "How do we align incentives so we pay more for prevention than for solving the disaster after it happens?" asks Donald R. Fischer, chief medical officer at Highmark.
UPMC's Roth says that improving the quality of care may also mean challenging a bedrock belief: that each patient is unique and that doctors must bring individualized judgment to each case. This view "has a kind of appeal to it for both the profession and patients," says Roth, "but it is not so." Most illnesses and injuries can best be treated by standardizing care, he argues. The goal is to "industrialize every process we can."
This idea horrifies some doctors, but businesses and insurance companies, who pay many of the bills, are cheering Roth on. "We know if you take beta blockers, you are much less likely to have a heart attack," explains Helen Darling, president of the Washington-based National Business Group on Health, which represents major employers. "We can reward you for meeting those standards."
Independence Blue Cross has gone a step further. It gives physicians lists of members with chronic conditions such as diabetes and asthma. The list includes the recommended treatments and tells who has received them. "Then when a patient shows up, the missing services can be provided," explains Dr. I. Steven Udvarhelyi, senior vice-president at the insurer. Doctors, who were leery at first, have embraced the plan.
Of course, you have to get people into physicians' offices. To do this, several health plans and companies have teamed up with Health Dialog Analytic Solutions, which identifies employees or plan members with the greatest needs and reaches out through phone calls and mailings. "The touch is very soft," says Joe Checkley, director of global benefits at American Standard Cos (ASD ). "It's saying: 'Here are some tools for you, and what can I do to help?"'
The early results are good. At Independence Blue Cross, with about 2 million members, "we know that the program overall reduces medical costs by about 2%," says Udvarhelyi. "That's for the entire population, not just the people that we touch. For them the reduction is orders of magnitude larger." With efforts like these, treatments that do work are now getting to more of the people who need them.
Read article at the original source
Medical Guesswork | A Lumpectomy May Do It
Medical Guesswork | A Lumpectomy May Do It
BusinessWeek, May 29, 2006
For Jeanine Whitney, the diagnosis of breast cancer last June was bad enough. But when her doctor told her that her best chance was an immediate mastectomy, "I cried for 24 hours. I felt that part of my womanhood would have been taken," says Whitney, who works at an air conditioner factory in Rushville, Ind. Her employer, American Standard Cos., had a program to provide workers with unbiased information about the risks and benefits of potential treatments. Thanks to the program, Whitney learned that there was no evidence that a mastectomy would have a better outcome than a lumpectomy, provided the tissue around the lump was clear of cancer. Twenty years after treatment, the outcomes were the same, according to studies. "It was a total surprise," she recalls. She requested a lumpectomy, which was carried out in July, followed by seven weeks of radiation and six of recovery. Now, Whitney is grateful that she was able to get the information she needed to buck her doctor's recommendation. If Whitney had had to make a decision without that, she says she would have "ended up in the psychiatric ward."
Read article at the original source
BusinessWeek, May 29, 2006
For Jeanine Whitney, the diagnosis of breast cancer last June was bad enough. But when her doctor told her that her best chance was an immediate mastectomy, "I cried for 24 hours. I felt that part of my womanhood would have been taken," says Whitney, who works at an air conditioner factory in Rushville, Ind. Her employer, American Standard Cos., had a program to provide workers with unbiased information about the risks and benefits of potential treatments. Thanks to the program, Whitney learned that there was no evidence that a mastectomy would have a better outcome than a lumpectomy, provided the tissue around the lump was clear of cancer. Twenty years after treatment, the outcomes were the same, according to studies. "It was a total surprise," she recalls. She requested a lumpectomy, which was carried out in July, followed by seven weeks of radiation and six of recovery. Now, Whitney is grateful that she was able to get the information she needed to buck her doctor's recommendation. If Whitney had had to make a decision without that, she says she would have "ended up in the psychiatric ward."
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?"'
Read 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
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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