COVER STORY BusinessWeek
MAY 29, 2006 issue
From heart surgery to
prostate care, the health industry knows little about which common treatments
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
For Eddy, this is one small step toward solving the thorniest riddle in medicine
-- a dark secret he has spent his career exposing. "The problem is that we
don't know what we are doing," he says. Even today, with a high-tech
health-care system that costs the nation $2 trillion a year, there is little or
no evidence that many widely used treatments and procedures actually work better
than various cheaper alternatives.
This judgment pertains to a shocking number of conditions or diseases, from
cardiovascular woes to back pain to prostate cancer. During his long and
controversial career proving that the practice of medicine is more guesswork
than science, Eddy has repeatedly punctured cherished physician myths. He
showed, for instance, that the annual chest X-ray was worthless, over the
objections of doctors who made money off the regular visit. He proved that
doctors had little clue about the success rate of procedures such as surgery for
enlarged prostates. He traced one common practice -- preventing women from
giving birth vaginally if they had previously had a cesarean -- to the
recommendation of one lone doctor. Indeed, when he began taking on medicine's
sacred cows, Eddy liked to cite a figure that only 15% of what doctors did was
backed by hard evidence.
A great many doctors and health-care quality experts have come to endorse Eddy's
critique. And while there has been progress in recent years, most of these
physicians say the portion of medicine that has been proven effective is still
outrageously low -- in the range of 20% to 25%. "We don't have the evidence
[that treatments work], and we are not investing very much in getting the
evidence," says Dr. Stephen C. Schoenbaum, executive vice-president of the
Commonwealth Fund and former president of Harvard Pilgrim Health Care Inc.
"Clearly, there is a lot in medicine we don't have definitive answers
to," adds Dr. I. Steven Udvarhelyi, senior vice-president and chief medical
officer at Pennsylvania's Independence Blue Cross.
What's required is a revolution called "evidence-based medicine," says
Eddy, a heart surgeon turned mathematician and health-care economist. Tall,
lean, and fit at 64, Eddy has the athletic stride and catlike reflexes of the
ace rock climber he still is. He also exhibits the competitive drive of someone
who once obsessively recorded his time on every training run, and who still
likes to be first on a brisk walk up a hill near his home in Aspen, Colo. In his
career, he has never been afraid to take a difficult path or an unpopular stand.
"Evidence-based" is a term he coined in the early 1980s, and it has
since become a rallying cry among medical reformers. The goal of this movement
is to pierce the fog that envelops the practice of medicine -- a state of
ignorance for which doctors cannot really be blamed. "The limitation is the
human mind," Eddy says. Without extensive information on the outcomes of
treatments, it's fiendishly difficult to know the best approach for care.
The human brain, Eddy explains, needs help to make sense of patients who have
combinations of diseases, and of the complex probabilities involved in each. To
provide that assistance, Eddy has spent the past 10 years leading a team to
develop the computer model that helped him crack the diabetes puzzle. Dubbed
Archimedes, this program seeks to mimic in equations the actual biology of the
body, and make treatment recommendations as well as figure out what each
approach costs. It is at least 10 times "better than the model we use now,
which is called thinking," says Dr. Richard Kahn, chief scientific officer
at the American Diabetes Assn.
Can one computer program offset all the ill-advised treatment options for a
whole range of different diseases? 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
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.
"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
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
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
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
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
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?"'
By John Carey
Original article posted at http://www.businessweek.com/magazine/content/06_22/b3986001.htm
JULY 18, 2005
questioning whether bypasses and angioplasties necessarily prolong patients'
Surgery Worth It?
You start breathing hard after
climbing stairs, and your chest hurts. You go to your doctor. Scans reveal that
arteries feeding your heart are severely narrowed. Your doctor sends you to the
hospital for coronary bypass surgery or angioplasty to restore the blood flow to
your heart. Despite the trauma of surgery, you're glad the blockage was caught
in time, saving you from a potentially fatal heart attack.
There's just one problem with this happy tale of modern medicine: More and more
doctors are questioning whether such heart procedures are actually extending
patients' lives. One of them, Dr. Nortin M. Hadler, professor of medicine at the
University of North Carolina at Chapel Hill and author of The Last Well
Person, is urging the U.S. medical Establishment to rethink its most basic
precepts of cardiovascular care. Bypass surgery in particular, he says,
"should have been relegated to the archives 15 years ago."
That is an extreme view that is disputed by cardiac surgeons. "The reason
thousands and thousands of bypass surgeries have been done is that [the
procedure] is successful," says Dr. Timothy J. Gardner, co-editor of Operative
Cardiac Surgery and a cardiothoracic surgeon at Christiana Care Health
System in Wilmington, Del.
Nevertheless, the data from clinical trials are clear: Except in a minority of
patients with severe disease, bypass operations don't prolong life or prevent
future heart attacks. Nor does angioplasty, in which narrowed vessels are
expanded and then, typically, propped open with metal tubes called stents.
"People often believe that having these procedures fixes the problem, as if
a plumber came in and fixed the plumbing with a new piece of pipe,"
explains Dr. L. David Hillis, professor of cardiology at the University of Texas
Southwestern Medical School. "But it fundamentally doesn't fix the
With doctors doing about 400,000 bypass surgeries and 1 million angioplasties a
year -- part of a heart-surgery industry worth an estimated $100 billion a year
-- the question of whether these operations are overused has enormous medical
and economic implications. "It is one of the major issues in cardiology
right now," says Dr. David Waters, chief of cardiology at the University of
California at San Francisco.
It is also part of a far broader problem -- what some health-care experts call
the medicalization of life. "None of us will live long without headache,
backache, heartache, heartburn, diarrhea, constipation, sadness, malaise, or
other symptoms of some kind," argues Hadler. Yet under relentless
bombardment by messages from the pharmaceutical and health-care industries,
Americans increasingly believe that these symptoms -- and many others -- are
conditions that can and should be cured. "We have an image of ourselves as
invincible and powerful and able to overcome all odds," Hadler says.
"And the lay press is too quick to talk about the latest widget and gizmo
without asking what it is and does it work."
HIGHER COST, BIGGER RISK
Indeed, there is compelling evidence that more health care and more aggressive
treatment across the complete spectrum of illnesses is not necessarily better.
When Dr. Elliott S. Fisher, professor of medicine at Dartmouth Medical School,
first looked at regional differences in health-care spending in the U.S., he
assumed that people in areas with lower expenditures would have worse health
than people in regions where spending was 1 1/2 to 2 times as high because they
were failing to receive needed care. It turned out that the opposite was true.
"Patients have a substantial increased risk of death if cared for in the
high-cost systems," he says. Why? For one thing, additional doctor visits
and testing often lead to unnecessary procedures and hospitalizations, which
carry risks. "My data suggest that we are wasting 30% of health-care
spending on stuff with no benefit and perhaps causing harm," says Fisher.
International comparisons support his reasoning. The U.S. spends 2 1/2 times as
much as any other country per person on health care, but that doesn't translate
into better outcomes, according to studies that compare such indicators as
fatality rates after a heart attack and length of survival after a kidney
transplant. That suggests that "the investment in health care in the U.S.
is just not paying off," says Gerard Anderson, director of the Center for
Hospital Finance & Management at Johns Hopkins Bloomberg School of Public
Health and co-author of a 2004 study that looked at 21 different health-quality
indicators in five nations.
Similar comparisons can help pinpoint dubious treatments. The classic case:
tonsillectomy. In the early 1970s, Dr. John E. Wennberg, now director of the
Center for Evaluative Clinical Sciences at Dartmouth Medical School, showed that
some hospitals removed tonsils 10 times as often as others. But the children in
areas with low rates weren't worse off, so the operation fell out of favor. More
recently, Dr. James N. Weinstein, chair of orthopedic surgery at
Dartmouth-Hitchcock Medical Center, found that people with back pain are up to
20 times as likely to have back surgery in some parts of the country as in
others. Yet it's not clear that they do better as a result. Weinstein is
comparing the outcomes in patients who get different treatments, from rest and
physical therapy to spinal fusion. Meanwhile, he says, "billions of dollars
are being spent without good information."
This is of obvious concern to those who pay for health care, from the government
to private insurers, which are struggling to better balance costs and benefits.
And nowhere are the financial and health stakes higher than in the area of
cardiac surgery. U.S. patients and insurers will spend $3.4 billion this year on
drug-coated stents from suppliers Boston Scientific Corp. (BSX
) and Johnson & Johnson (JNJ
), according to Citigroup. At many hospitals, cardiac units have become major
profit centers. "We've shown that it is a lucrative area for
hospitals," says Paul B. Ginsburg, president of the Center for Studying
Health System Change. But are heart procedures always the best path for patients
who currently get them?
The answer seems to be no. As Hadler describes in his book, data from
bypass-surgery clinical trials in the late 1970s show that the procedure extends
life or prevents heart attacks only in a small percentage of patients -- those
with severe disease. More recent trials with angioplasty show it reduces deaths
mainly just in emergencies. "For people in the throes of heart attacks,
opening the artery definitely prolongs life," says UCSF's Waters. Not so
for patients with stable chronic disease. "The overwhelming number of heart
procedures done these days do not affect patients' life span at all," says
The latest thinking on heart attacks may explain why not. In the traditional
view, the slow accumulation of plaque inside arteries gradually narrows the
vessels. Reduced blood flow causes chest pain, or angina. Eventually the
arteries are blocked, bringing on heart attacks. Newer evidence, however, pins
the blame not on this gradual narrowing but on unstable plaque that breaks off
and causes clots. The clots are what obstruct the arteries, causing the heart
attacks -- which is why so many such events are unexpected and why "there
is no evidence that opening chronically narrowed arteries reduces the risk of
heart attack," says Waters.
DIET AND LIFESTYLE
A better way to lower heart-attack risk is to fight the unstable plaque with
aggressive cholesterol-reducing drug therapy, diet, and lifestyle changes, many
cardiac physicians say. That can be a tough sell to patients who want a quick
fix, says Hillis. "Medical therapy is just not as sexy as doing a
procedure," he explains. "The assumption our society makes is that the
more aggressive your medical care is, the better it is. It's not true. But if I
explain to a patient why he doesn't need surgery, 9 times out of 10 he will go
across town and find someone who will do the procedure."
The surgeries do relieve angina symptoms -- and for some doctors that's a slam
dunk. Emory University cardiologist Dr. Robert A. Guyton, co-chair of the
American College of Cardiology and the American Heart Assn. committee that wrote
the current bypass-surgery guidelines, points to patients disabled by pain and
shortness of breath who, a month after bypass surgery, "are walking around
as healthy as you or I," he says. "To say the whole operation ought to
be scrapped is nuts." Similarly, angioplasty eases the often crippling pain
of angina. "There is quite a lot of good evidence for symptom relief,"
says Dr. Robert Henderson, a cardiologist at Nottingham City Hospital in Britain
and co-investigator for a key angioplasty clinical trial.
Critics such as Hadler, on the other hand, emphasize the risks. Not only is
there a 1% to 2% chance of dying during a bypass operation, he explains, there
is a high risk of complications and a 40% chance of cognitive deficits. The
healthy, active post-surgery patient is an "urban legend," he says.
"An alarming number never return to the workforce or describe themselves as
Recent studies even raise questions about whether surgery causes the symptom
relief. In June, Harvard Medical School associate professor of medicine Dr.
Roger J. Laham reported on follow-up results of a randomized trial looking at
laser surgery to improve blood flow. Patients who got the surgery had
significantly less pain and improved heart function. But so did patients who had
a sham operation -- the equivalent of a placebo. After 30 months the placebo
effect was still there. Scans and other tests showed physiological gains in
blood flow among only those who thought they had been operated on. A similar
large placebo effect might explain "most of the benefits that we've seen so
far with balloon angioplasty and bypass surgery," Laham says.
There are also fresh concerns about the safety of drug-coated stents, now widely
used in angioplasty. When doctors first tried to open clogged arteries with a
balloon, they found that arteries soon closed again. So they began inserting
metal mesh stents to hold them open. When arteries continued to clog up again,
companies devised stents impregnated with drugs that slow the growth of cells,
reducing chances that patients would have to have their arteries opened again.
First approved in April, 2003, drug-coated stents account for 88% of the stents
used in the U.S. But when pathologist Dr. Renu Virmani, medical director of
CVPath, a research service of the International Registry of Pathology, examined
the hearts or heart vessels of 39 patients who died after getting the new stents,
she found clots in 11 cases that developed more than 30 days after the
procedure. The sample is small, and it's not clear that the clots caused the
deaths. But it's a big jump from her experience with patients who died after
getting bare-metal stents. Just 12.5% of them had late-developing clots.
What worries some doctors is that people getting the new stents might have a
higher risk of clots, which then could cause heart attacks more than a month
after the procedure. "Out of 100 patients who get a drug-coated stent vs. a
bare-metal stent, maybe 10 will avoid a repeat procedure," says Dr. Eric J.
Topol, chief of cardiology at the Cleveland Clinic Foundation. "But how
many will wind up with a heart attack or death? Maybe one in 1,000? We just
don't have that nailed down yet." Drug-coated stentmakers Boston Scientific
and Johnson & Johnson say their clinical trials show no such increased risk
of late-developing clots.
Cardiac surgeons readily admit there are big unanswered questions. "We can
handle the criticisms, and we should be accountable," says cardiothoracic
surgeon Gardner. "But there is plenty of hard work going on to try to
determine the appropriate patients for whom such treatments are necessary."
There are also large clinical trials under way comparing surgery with
cholesterol-reducing drugs and other medical treatment, which will provide
better answers. If the trials show no benefit to surgery compared to medicine,
"it will be a serious challenge to the coronary-intervention
industry," says Dr. Robert H. Jones, distinguished professor of
cardiothoracic surgery at Duke University Medical Center. His prediction?
"I'm a surgeon, so I think surgery will hold up."
The answers still may not be definitive, however, because medicine continues to
advance. "Every time these studies come out and show that revascularization
[improving blood flow] doesn't do much, cardiologists say: 'Well, that study was
started four years ago, and now we have shinier stents, and the results are
better,"' notes UCSF's Waters. "But medical therapy [with drugs] is
getting much, much better, too." Harvard's Laham suggests that as many as
400,000 of the angioplasties done in the U.S. each year may be medically
unwarranted. "I'm sure we are way overtreating our patients," he says.
Some scientists argue that the rational solution is to let patients decide for
themselves. But that requires providing detailed information about the risks and
benefits of medical procedures, such as coronary surgery -- including the
unknowns. In trials where one group gets the information and the other group
receives no special attention, the well-informed patients opt for more invasive,
aggressive approaches 23% less often, on average, than the other group. Without
this full information, "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 Annette M. Cormier
O'Connor, clinical epidemiologist at Ottawa Health Research Institute and a
leader in this field of so-called decision aids.
It's a model approach for medicine in general. As Hadler argues, the
exaggeration regarding benefits goes far beyond heart surgery. Too many common
conditions are viewed as diseases needing treatment, and too many treatments of
uncertain benefit are used too often. "What Hadler does is question the
soundness of that thinking in a very profound way," says Dr. Glenn D.
Pomerantz, senior vice-president for global innovation at Cigna (CI
). Hadler hopes that enlightening people about the limitations of medicine will
help them worry less and stay well longer. It also could help cure an ailing
health-care system, making it more rational. In the end, few doctors will object
to the basic prescription: Avoid drastic procedures that probably won't help and
might actually do harm.
By John Carey, with Amy Barrett in Philadelphia
Original article posted at http://www.businessweek.com/magazine/content/05_29/b3943037_mz011.htm?chan=tc