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The Perils of Prevention (NYT March 16, 2003)
But while this sort of prevention clearly works, a troubling trend has taken
root when it comes to doctors actively treating patients with drugs or
procedures to prevent disease. Dr. Eric Schneider, an assistant professor of
medicine at the Harvard School of Public Health and Schneider was the lead investigator on a study that looked at angioplasty, a
common procedure that is often viewed as a preventive measure. Angioplasty is
meant to treat the physical symptoms of heart disease -- shortness of breath
and angina pectoralis, or chest pain -- and can be a
lifesaver when administered within the first few hours of a heart attack.
During the procedure, an operation that can be done with local anesthesia, a
doctor threads a special wire fitted with a tiny deflated balloon, no wider
than a pencil lead, through the abdominal artery up into the coronary arteries,
which supply blood to the heart. On a cine-angiogram, a kind of X-ray movie, you
can literally see a clot blocking the blood flow to the heart. That clot is
squashed against the wall of the artery when the balloon is blown up. Once the
balloon is deflated, the clot breaks up and blood begins flowing into the heart
muscle. Alternatively, cardiologists can install a stent,
or steel mesh tube, which is expanded inside the artery and left in place. In 2000, a balloon or a stent saved the lives of
many Americans who were given an angioplasty while in the midst of a heart
attack. But most of the million angioplasties performed were done on people who
were not in imminent danger of dying. Schneider's Harvard study suggests that
more than two-thirds of these so-called elective angioplasties (not done to
save the patient's life, but to prevent future symptoms) were performed on
patients who, by criteria accepted by cardiologists themselves, may have stood
to gain little or nothing from the procedure. When Schneider's group looked at 828 angioplasties done on Medicare
beneficiaries, they found that only about a third of the patients could have
expected to benefit from the procedure. Another 14 percent of the angioplasties
were completely inappropriate, either because the patients had no physical
symptoms or the narrowing in their arteries was so slight it could not possibly
be causing any problems or their condition was so severe that they needed
cardiac bypass operations. For the remaining half of the patients in the study,
it was impossible to decide if they stood to benefit. Why would cardiologists want to subject patients to an elective treatment
they might not need? Part of the answer is that huge numbers of Americans --
about two million a year -- are being given angiograms, the imaging test that
shows narrowings, or stenosis,
in the coronary arteries. Once cardiologists see a narrowing, it is very
difficult not to want to do something about it. Dr. Eric Topol,
chairman of the department of cardiovascular medicine at the Cleveland Clinic,
calls it ''the occulostenotic reflex.'' ''You see a
narrowing, and you think, We need to do a stent,'' he says. ''That is a problem, because so many narrowings are innocent -- they don't need a stent; they aren't tied to symptoms in the patient. But you get on the train, and you can't get off once it's moving.''
Too many cardiologists, Topol says, do not do enough
to treat the chronic condition, the underlying problems like high cholesterol
that are causing the narrowing. They need to encourage their patients to adopt
a healthier lifestyle, for instance, and to prescribe anti-cholesterol
medication and aspirin. ''There is a big force to do angioplasty procedures,''
he says. ''It can be done quickly; it is quite safe; and cardiologists find it relatively
lucrative -- and that's not helping matters.'' But also driving many elective
angioplasties is the unspoken hope that the operation will be a magic bullet, a
quick and safe procedure that will prevent a heart attack sometime in the
future. Unfortunately, at this point there is no evidence to support that idea. It
is wishful thinking that angioplasty prevents future heart attacks, explains
Dr. Robert Lager, a cardiologist at the Washington Hospital Center in the
District of Columbia. ''But patients want to believe it. You can see the look
in their eyes when you tell them that this is a chronic disease. And it's easy
for us as doctors to believe it too. But angio was
designed to treat symptoms.'' Angioplasty is a template for the manner in which many procedures came into
widespread use in American medicine's laudable but often flawed effort to
prevent disease. First, doctors discover that a procedure saves lives or
effectively treats an acute condition. Next they begin applying it to patients
whose disease is not so advanced in the hope that they will keep the condition
from worsening. And then they begin looking for earlier and earlier signs of
the disease in patients who feel perfectly healthy. Prevention has become the
doctor's watchword, the mantra that drives the use -- and often misuse -- of
procedures and diagnostic tests in every branch of medicine from cardiology to
psychiatry. Its pursuit has blurred the boundaries of medical futility and
helped fuel the conviction shared by doctors and patients that it is better to
err on the side of doing more rather than less.
Today, the number of tests has exploded. ''We no longer just treat sick
patients, but instead we look at well patients to find evidence of disease,''
says Dr. Stephen Baker, chairman of the radiology department at the A few diagnostic tests -- for instance, the Pap smear, the colonoscopy and
the DEXA scan for osteoporosis -- have proved to be effective tools for
defensive medicine, allowing doctors to catch disease and treat it before
symptoms appear. But many other diagnostic tests, which have their places if a
patient has symptoms, are given routinely to apparently healthy people in the
name of prevention. They are having the perverse effect of benefiting only a
small minority of patients while exposing the majority to invasive, often
risky, treatment they don't necessarily need. This is true for mammography and the prostate specific antigen, or P.S.A., test
-- two screening tests that most Americans unvaryingly believe will help thwart
an untimely death. On the surface, the logic seems obvious. Prostate cancer is
the second most common cause of cancer death among men, after lung cancer, and
breast cancer ranks second for women. Both tests can catch tumors when they are
tiny. High-resolution mammography can now detect breast cancers not much bigger
than two letters printed on this page, while the P.S.A. test catches prostate
tumors on average 11 years before a digital rectal exam. But if early diagnosis
really worked, then the mortality rate, or deaths per 100,000 in the
population, should go down as more and more people are screened. Some cancer
epidemiologists and doctors now argue that there is little evidence that either
screening test has lowered the death rate significantly for its respective
cancer. That is because tumors come in many types, only some of which will never
become aggressive enough to threaten the patient's life. Many tumors will sit
around for years, causing few if any symptoms, and the person will die of
something else before the cancer becomes a problem. On the flip side, many
dangerous tumors cannot be cured with current treatments, no matter how early
they are caught. Unfortunately, radiologists and pathologists can't tell with
much certainty how aggressive a particular tumor is going to be. ''Imaging has
improved so much, we can find things that we really don't know enough about,''
says Dr. William Black, a radiologist at Dartmouth Medical School. In the face
of this uncertainty, doctors say they must err on the side of caution and treat
practically every tiny tumor as if it were potentially deadly in the hope of
curing at least a few. But that means that widespread screening for prostate and breast cancer has
resulted in huge numbers of patients suffering the side effects of unnecessary
medicine. A study published last October in BMJ (formerly the British Medical
Journal) compared P.S.A. testing rates in the region around Seattle and in
Connecticut between 1987 and 1997. Men in Seattle were 5.39 times as likely to
get a P.S.A. test as men in Connecticut and 5 times as likely to undergo
surgical removal of the prostate. Yet there was no significant difference in
the death rate from prostate cancer between the two regions. Prostate removal
is a delicate surgical procedure that renders many patients impotent,
incontinent or both. In a study of patients at Harvard University hospitals,
where you might expect the best outcomes, the majority of men were impotent a
year after their surgery. It is less clear that mammograms are not helpful. But there is still little
evidence that they are. Seven different clinical trials conducted since the
1960's, involving well over 100,000 women in the United States, Canada and
Europe, have tried to determine the benefits of mammography. The most recent
analyses of those trials have found critical flaws in their design, leaving an
increasing number of cancer experts to conclude that there is no clear evidence
to suggest that mammography is saving lives. The same cycle is coming into play for detecting kidney cancer. More and
more tumors are being spotted on the kidneys by the full-body CT scan, a new
technology that is being heavily marketed by large academic medical centers and
hundreds of freestanding clinics around the country. But as with breast or
prostate tumors, many of these tumors may turn out to be, on closer inspection,
simply benign lumps that appeared to be cancer at first. Unfortunately, closer
inspection usually means a surgical procedure. Baker cites a study that
indicates that 85 percent of kidney spots that show up on a scan will turn out
to be false-positives. He also explains that a 40-to-60-year-old man who
undergoes a full-body scan has a 1 in 20,000 chance of having malignant kidney
cancer at the time. When doctors start looking for disease in healthy people,
Baker says, ''the odds are in favor of making mischief
rather than a cure.'' Take the DEXA, or dual-energy X-ray absorptiometry
scan, which is one of the screening tests that when used properly can help
prevent disease. Doctors routinely use the DEXA on women 65 and older to
diagnose osteoporosis, or thinning bones, one of several risk factors for
fractures in the elderly. When the DEXA scan first came into use a decade ago,
a panel of international experts convened to decide the cutoff point for
diagnosing osteoporosis, drawing the line at bone density that was a certain
level below that of the average 25-year-old woman. The panel's standard has
helped doctors to identify women at highest risk for fractures and treat them
with drugs like estrogen and Fosamax, which slow bone
loss. Doctors get into trouble when they try to stem osteoporosis in younger and
healthier women. At the same time that the expert panel set the standards for
osteoporosis, it also invented a new term, ''osteopenia,''
for women who had suffered a little bone loss but not enough to put them in the
category of osteoporosis. The panel hoped that women would be screened once
soon after menopause and that a diagnosis of osteopenia
would serve as a warning sign for them to stop smoking and step up their
efforts to get enough calcium and exercise, primary prevention that can slow
the loss of bone. Instead, a diagnosis of osteopenia
has led many doctors to prescribe Fosamax and other
drugs immediately rather than waiting for osteoporosis. ''Doctors and their patients don't even know what osteopenia
means,'' says Susan Love, a breast-cancer surgeon and frequent critic of many
postmenopausal treatments. There is no evidence to suggest that earlier
treatment will be any more effective in arresting fractures than waiting for
true osteoporosis. In fact, some animal studies now under way are suggesting
quite the opposite, that long-term use of the drugs
may cause bones to become more brittle, Love says, ''and we are prescribing
these drugs to women who might or might not suffer a fracture 15 or 20 years
down the road.''
But this figure is accurate only for the patient whose carotid arteries are
at least 70 percent blocked and who has already experienced either a full-blown
stroke or a ministroke, a temporary loss of blood
flow to part of the brain. Epidemiologists estimate that 3 out of 10 people who
fall into this category will suffer a stroke within five years. Undergoing
carotid endarterectomy reduces their risk to 1 in 10.
But most of the endarterectomies in this country
aren't performed on these high-risk patients, but rather on people whose
chances of stroke are significantly lower. In January, Dr. Peter Rothwell, a British neurologist, published results from a
study of more than 6,000 patients pooled from several large European and
American clinical trials. The study confirmed that the operation really does help
avert strokes in people at the highest risk. But for patients who had only
moderately blocked arteries the surgery's benefit is offset by the 6 to 7
percent risk of stroke or death posed by the procedure itself. As for patients
with only mild narrowings, the procedure increased
the possibility of stroke. As the Doppler screening test becomes increasingly omnipresent, more and
more people are being tested for blockages. Those tests often lead to
procedures. And two-thirds of carotid endarterectomies
performed in this country are on people who have no symptoms. That means that
last year about 100,000 Americans underwent a procedure that not only had
little chance of benefiting them; it also caused some of them serious harm. At
an average cost of $15,000 per endarterectomy, that
is $1.5 billion the health care system could have put to better use. Though some doctors are doing carotid endarterectomies
on patients who will not benefit, how should any doctor make a decision about
the patients who are in that gray area where there is no evidence that a test
or treatment will actually save their lives, but also no evidence that it
won't? And how do you keep patients from demanding those interventions in order
to be better safe than sorry? Some doctors are now testing a new method of care
called ''shared decision making,'' which is showing that the choices patients
make are connected to what they know. Rather than trying to determine what the
best course of action is -- whether to perform an angioplasty, say, or a P.S.A.
test -- a doctor gives the patient a videotape to watch at home that lays out
in clear and simple terms what is known about the test or procedure being
considered, and what the potential dangers are. Patients, it turns out, are
often more wary of the risks of medical intervention than their doctors are. In
a recent study conducted at the Dartmouth-Hitchcock Medical Center in Hanover,
N.H., researchers compared two groups of people with severe back pain caused by
a ruptured disc. One group simply talked to their surgeons about having a back
operation. The other group took home a video that described the possible risks
and benefits. The group that saw the video was 30 percent less likely to choose
surgery compared with the other patients. Shannon Brownlee is a senior fellow at the New America Foundation.
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