Wednesday, August 17, 2011
Dr. Stephen Smith, Professor emeritus of family medicine at Brown University School of Medicine, tells his physician not to order a PSA blood test for prostate cancer or an annual electrocardiogram to screen for heart irregularities, since neither test has been shown to save lives. Rather, both tests frequently find innocuous quirks that can lead to a dangerous odyssey of tests and procedures. Dr. Rita Redberg, professor of medicine at the University of California, San Francisco, and editor of the prestigious Archives of Internal Medicine, has no intention of having a screening mammogram even though her 50th birthday has come and gone. That's the age at which women are advised to get one. But, says Redberg, they detect too many false positives (suspicious spots that turn out, upon biopsy, to be nothing) and tumors that might regress on their own, and there is little if any evidence that they save lives.
These physicians are not anti-medicine. They are not trying to save money on their copayments or deductibles. And they are not trying to rein in the nation's soaring health-care costs, which at $2.7 trillion account for fully one sixth of every dollar spent in the U.S. They are applying to their personal lives a message they have become increasingly vocal about in their roles as biomedical researchers and doctors: more health care often means worse health. "There are many areas of medicine where not testing, not imaging, and not treating actually result in better health outcomes," Redberg says. In other words, "less is more." Archives, which is owned by the American Medical Association, has been publishing study after study about tests and treatments that do more harm than good.
That less health care can lead to better health and, conversely, that more health care can harm health, runs counter to most patients' conviction that screenings and treatments are inherently beneficial. That belief is fueled by the flood of new technologies and drugs that have reached the market in the past two or three decades, promising to prevent disease and extend life. Most of us wouldn't think twice if our doctor offered a test that has the power to expose a lurking tumor, or a clogged artery, or a heart arrhythmia. Better to know—and get treated—than to take any risks, the reasoning goes.
In fact, for many otherwise healthy people, tests often lead to more tests, which can lead to interventions based on a possible problem that may have gone away on its own or ultimately proved harmless. Patients can easily be fooled when a screening test detects, or an intervention treats, an abnormality, and their health improves, says cardiologist Michael Lauer of the National Heart, Lung, and Blood Institute. In fact, says Lauer, that abnormality may not have been the cause of the problem or a threat to future health: "All you've done is misclassify someone with no disease as having disease."
This realization comes at a time when Medicare has emerged as a fat target in the debate over taming the deficit, with politicians proposing to slash costs by raising the age of eligibility or even eliminating the program. Experts estimate that the U.S. spends hundreds of billions of dollars every year on medical procedures that provide no benefit or a substantial risk of harm, suggesting that Medicare could save both money and lives if it stopped paying for some common treatments. "There's a reason we spend almost twice as much per capita on health care [as other developed countries] with no gain in health or longevity," argues Dr. Steven Nissen, the noted cardiologist at the Cleveland Clinic. "We spend money like a drunken sailor on shore leave."
Many medical advances, of course, have saved lives and eased suffering for millions of people. Screening tests like mammograms can lead to early treatment of breast cancer, especially for women with hereditary risk or a strong family history of the disease. For cancer patients who report back pain, MRIs can prove invaluable for spotting tumors that have metastasized to the bones, allowing doctors to intervene before it's too late. The years between 1980 and 2004 saw a 50 percent decline in the death rate from coronary heart disease thanks to better treatments and drugs that reduce cholesterol and blood pressure. At least 7,300 lives are saved every year thanks to colonoscopies.
The dilemma, say a growing number of physicians and expert medical panels, is that some of this same health care that helps certain patients can, when offered to everyone else, be useless or even detrimental. Some of the most disturbing examples involve cardiology. At least five large, randomized controlled studies have analyzed treatments for stable heart patients who have nothing worse than mild chest pain. The studies compared invasive procedures including angioplasty, in which a surgeon mechanically widens a blocked blood vessel by crushing the fatty deposits called plaques; stenting, or propping open a vessel with wire mesh; and bypass surgery, grafting a new blood vessel onto a blocked one. Every study found that the surgical procedures didn't improve survival rates or quality of life more than noninvasive treatments including drugs (beta blockers, cholesterol-lowering statins, and aspirin), exercise, and a healthy diet. They were, however, far more expensive: stenting costs Medicare more than $1.6 billion a year.
If that finding makes you scratch your head—how can propping open a narrowed blood vessel not be wonderfully effective?—you're not alone. Many cardiologists had the same reaction when these studies were published. It turns out that the big blockages that show up on CT scans and other imaging, and that were long assumed to cause heart attacks, usually don't—but treating them can. That's because when you disrupt these blockages through surgery, you "spray a whole lot of debris down into the tiny blood vessels, which can trigger a heart attack or stroke," says Nortin Hadler, a professor of medicine at the University of North Carolina, whose book on overtreatment in the elderly, Rethinking Aging, will be published next month. Many of the 500,000 elective angioplasties (at least $50,000 each) performed every year are done on patients who could benefit more from drugs, exercise, and healthy eating.
New technology has sometimes made the problem more acute. Where once arterial blockages were detected by chest X-ray, now doctors can use cardiac CT angiography, which shows the heart and coronary arteries in dramatic 3-D. When it was introduced a decade ago to screen for cardiovascular disease, it seemed almost miraculous: a 2005 cover of Time trumpeted that it could "stop a heart attack before it happens." Difficult as it is to believe, however, there can be such a thing as too much information, especially from new imaging technology. "Our imaging and diagnostic tests are so good, we can see things we couldn't see before," says Lauer of the National Heart, Lung, and Blood Institute. "But our ability to understand what we're seeing and to know if we should intervene hasn't kept up."
In a recent study, John McEvoy, a heart specialist at Johns Hopkins Medical Institutions, and colleagues found that 1,000 low-risk patients who had CT angiography had no fewer heart attacks or deaths over the next 18 months than 1,000 patients who did not undergo the screening. But they did have more drugs, tests, and invasive procedures such as stenting, all of which carry a risk of side effects, surgical complications, and even death. The CT itself has a potential side effect: by exposing patients to high levels of radiation, it raises the risk of cancer. "Low-risk patients without symptoms don't benefit from CT angiography," says McEvoy, though high-risk patients with heart disease might.
The Cleveland Clinic's Nissen has seen firsthand what happens when doctors, armed with too much information, perform what turn out to be unnecessary procedures. In 2009 a 52-year-old woman with chest pain underwent a cardiac CT at a community hospital. Neither her LDL (bad) cholesterol nor her C-reactive protein (another risk factor for heart disease) were elevated. But since the CT showed several coronary plaques, her physicians performed coronary angiography. Complications ensued, and the woman wound up undergoing more procedures, one of which tore an artery. She eventually went to the Cleveland Clinic for a heart transplant—not because she had heart disease when it all started, says Nissen, but because of the cascading interventions triggered by the CT.
Nissen regularly counsels asymptomatic, low-risk patients against having cardiac CT, echocardiograms, and even treadmill stress tests; studies show they produce many false positives, leading to risky interventions. Even a clean scan can lead to worse health, if it makes people believe they can eat whatever they want and stop exercising. "I've had colleagues gain weight after a negative heart scan," apparently figuring they were home free, says UCSF's Redberg.
Radiologists and other physicians who diagnose or treat back pain have their own version of the CT: it's called magnetic resonance imaging, or MRI. Just as cardiac CT makes sense in principle, so does getting a high-resolution image of the spine if someone is suffering lower back pain with no clear cause. An MRI typically costs about $3,000 and is designed to spot everything from bulging discs to hairline fractures. Find any of those things, the logic goes, and you can treat the problem surgically. But there's a fundamental flaw: clinical trials have shown that back surgery, including vertebroplasty (putting special cement on a tiny spinal fracture) and spinal fusion, is no more effective at alleviating ordinary pain than plain-old rest and mild exercise. But like any surgery, it carries risks. Last year the American College of Physicians warned that "routine imaging [for low back pain] is not associated with clinically meaningful benefits but can lead to harms." That's because the "abnormalities" seen in an MRI often have nothing to do with the back pain (people without pain have them, too), but seeing something on a scan makes a physician feel compelled to get rid of it. "There is a longstanding fallacy among physicians that if you find something different from what you perceive to be 'normal,' then it must be the cause of the patient's problem," says UNC's Hadler.
Dr. James Goodwin, a geriatrician at the University of Texas Medical Branch, cites an extreme example of this fallacy in the case of a frail 84-year-old woman who was told by her gastroenterologist that it was time for another colonoscopy, just a few years after her last one showed no problems. She died when the procedure perforated her colon. Though this outcome is rare, the recommendation that led to the woman's death is all too common, says Goodwin, even though expert groups advise against screening colonscopies for anyone over 75 or who has had a normal result within the past 10 years. He says he was dumbfounded when his elderly patients kept receiving "reminders" from their gastroenterologists telling them it was time for another colonoscopy—seven or five or even two years after their last normal one.
Both curious and concerned, Goodwin launched a study of Medicare patients. Fully 46 percent had a screening colonoscopy fewer than seven years after a negative one. Making matters worse, many of them were over 80.
Medical practice also suffers from a kind of mission creep: if a treatment works in severe disease, some doctors assume it will work in milder disease. But that is not necessarily so. Antidepressants, for instance, have been shown in randomized trials to help with severe depression but not with moderate or mild depression, yet are widely prescribed for those conditions. Drugs called proton pump inhibitors (PPIs) are effective against gastric reflux and rare esophageal diseases as well as some ulcers, but at least half, and possibly 70 percent, of the 113 million U.S. prescriptions for PPIs each year are for conditions they don't help, such as run-of-the-mill stomachaches. PPIs can cause bone fractures, severe and hard-to-treat bacterial infections, and pneumonia. Millions of people are being put at risk unnecessarily, which is one reason treating adverse drug reactions costs the U.S. $200 billion a year.
Statins, common cholesterol-reducing drugs, may also not benefit some people who are taking them. Statins are proved to help people with both heart disease and high cholesterol, but not those with just high cholesterol. The drugs are nevertheless widely prescribed to patients who fit the latter description, despite adverse effects, such as severe muscle disease in up to 20 percent of patients. Similarly, cardiac resynchronization therapy, a special pacemaker that causes the right and left ventricles to beat in sync, can save the life of a patient with congestive heart failure whose ventricles are at least 150 milliseconds out of sync. Yet patients with a mistiming of 120-150 milliseconds are receiving the devices.
Low-tech tests should sometimes be avoided, too. In an Archives paper published this month, a panel of physicians, led by Brown's Smith, announced its first list of tests and treatments that should be dropped altogether for certain patients and ailments: antibiotics for sinus infections, imaging for low back pain, osteoporosis screening for women under 65, and electrocardiograms and other cardiac screening in low-risk patients. Even blood panels for healthy adults made the list. Today's comprehensive blood tests measure 15 or so enzymes, proteins, lipids, and the like. Yet by chance alone, if you test for 20 things, something will fall outside the bounds of "normal," often due to simple lab error.
Many doctors don't seem to be getting the message about useless and harmful health care. Medicare pays them more than $100 million a year for screening colonoscopies; some 40 percent are for people in whom they will almost certainly harm more than help. Arthroscopic knee surgery for osteoarthritis is performed about 650,000 times a year; studies show that it, too, is no more effective than placebo treatment, yet taxpayers and private insurers pay for it. And although several large studies, including the Occluded Artery Trial in 2006, have shown that inserting a stent to prop open a blocked artery more than 24 hours after a heart attack does not improve survival rates or reduce the risk of another coronary compared with drugs alone, the practice continues at a rate of 100,000 such procedures a year, estimate researchers led by Dr. Judith Hochman, a cardiologist at New York University. "We're killing more people than we're saving with these procedures," says UT's Goodwin. "It's as simple as that."
Dear Friends and Family,
The morning sun is shimmering off Snug Harbor this week and the skies over Cape Cod are as bountiful as the blueberries our girls picked this morning. The clear days and fresh fields are a welcome relief from a long spell in New York marked by "May Gray," "June Gloom," and this year's Summer Solstice, the Cloudiest Day of the Year.
Last week I went to visit a friend I hadn't seen in a while. I sat in his chair in New York's trendy Meatpacking District surrounded by disco balls, leopard divans, and dolls with pink hair. Michael Angelo (yes, that's his real name) gave me a hug as we talked about the horrendous ordeal that has elapsed since we last met. Then he went to work. It was 5:30 PM on the 365th day of my Lost Year, and I was about to do something I had not done in that entire time.
I was getting my hair cut.
Twelve months have passed since I first learned I had an osteosarcoma in my left femur. During my recent quarterly check-ups, I received much good news. There are no signs of cancer in my bones or lungs. My prosthesis is growing nicely into my femur. As Dr. Healey said, "You are on your way to recovery. Truly."
He then added, "But we both know …"
On the sobering front, the chemotherapy has left me with neuropathy in the tips of several fingers. The fibular graft is not fusing to my femur in quite the way we hoped, and I may have to have more surgery to correct it this fall. And my leg is still a burden. We reach this one-year milestone with relief, if not champagne. My Lost Year is over, but my long road continues.
Tuesday, August 16, 2011
Cancer Commons is a new patient-centric paradigm for translational medicine, in which every patient receives personalized therapy based upon the best available science, and researchers continuously test and refine their models of cancer biology and therapeutics based on the resulting clinical responses.
On television, the emergency room patients beat the odds. Their hearts get shocked back to life. Their organs get sewn up. They awaken to a handsome young physician's dazzling smile.
In real life, one in 500 ER patients—200,000 a year—dies under the bright lights of the emergency rooms. Another 500,000—3 percent—die during hospital stays following emergency treatment. Countless patients learn, from a doctor they have never seen before and may never see again, that they have fatal diseases. Others get treated, aggressively and repeatedly, for dangerous flare-ups in conditions like heart failure or emphysema without anyone having the time or the skills to explain that the chronic disease they have been living with is now the chronic disease that they are slowly dying from, a scenario Atul Gawande explored in his recent New Yorker piece on what doctors can do when they can no longer cure.
A Majority of Canadians Report They Are in Good Physical and Emotional Health, but Challenges With Wellness, Healthy Living and Chronic Disease Are on the Rise: Deloitte
Fifty-five per cent of Canadians rate their overall health as "excellent" or "very good" in 2011 - a decline from 2009 when 60 per cent said the same - and nearly two-thirds report high levels of emotional well-being, similar to two years ago. At the same time, Canadians are experiencing increased challenges as they try to adequately address wellness, healthy living and chronic disease. For example, over half of Canadians have been diagnosed with one or more chronic diseases. These are some of the findings of Deloitte's 2011 Survey of Health-care consumers in Canada: Key Findings, strategic Implications which surveyed over 2,300 adult Canadians to better understand the perspectives of Canadians as health-care consumers.
"While we note a decline compared to two years ago, the fact that a majority of Canadians continue to rate themselves as healthy is good news. Our survey shows we rank third in that self-assessment, just behind the U.S. (61 per cent) and the U.K. (56 per cent), and well ahead of the other nine countries we reviewed," says Mark Fam, Senior Manager, Deloitte National Health Services and lead author for the Canadian health consumer survey. "This is consistent with other findings in our study that indicate Canadians are generally satisfied with their health-care system, however we also see an increase in consumer demand for improvements to system performance and their access to health services that support their own wellness and care self-management."
But the new survey results also reveal major challenges, including increasing rates of chronic disease (52 per cent this year compared to 47 per cent in 2009), a development with significant implications in terms of health outcomes and income-generating capacity for many Canadians. "The number of Canadians giving high marks to their health climbs sharply (over 70 per cent) if we only look at those without chronic disease," Fam said. "In addition, one in seven Canadians now have responsibility for the care of family members or friends, an increase from 2009. Fam pointed out that this trend is growing and it represents major limitations on the caregivers' ability to earn income. "This is a challenge that continues to be a key element of the Canadian consumer health care experience," Fam said.
Now in its fourth year globally, and the second year for Canada, the 2011 survey continues to explore consumers' behaviours, attitudes, and unmet needs in six areas: wellness and healthy living; information resources; traditional health services; alternative health services; health insurance; health policy.
The new survey found that Canadians are experiencing a range of difficulties - from costs to information in order to fully navigate the system - in finding the resources they need to achieve effective self-care. As a result, survey respondents were in favour of innovations and solutions that help them manage their own care and that bring the health-care system as close as possible to the individual in order to meet evolving needs and expectations.
In commenting on these findings, Lisa Purdy, Partner, National Health Leader, Deloitte noted that the increasingly widespread use of preventive services - regular check-ups, screenings, supplements, nutritional foods - is a step in the right direction but that it needs to be enhanced with targeted encouragements such as tax-based incentives to promote healthy living. "Currently, women and older Canadians use preventive services the most, but younger Canadians indicate they would welcome new public tax models that reward healthy living," Purdy said.
She also emphasized the high interest shown by Canadians toward electronic tools that help manage their care and consolidate related information: Over 65 per cent of Canadians said they would favour having a government-provided electronic health record that could be used by themselves and their health providers; a similar number support medical devices that enable them to check their health condition and send information electronically to their doctor. "A strong majority of Canadians said they used the Internet in the past year for online banking, to purchase merchandise or reserve travel, so this is a trend our health-care system can adapt in order to meet the evolving needs of the population." Purdy also noted that consumers' concern over privacy and security of personal information is dropping: Fewer than a third of respondents say they are highly concerned about the security of their information stored online this year, compared to 34 per cent two years ago.
A new study suggests Americans with heart failure may benefit less from recommended medications than patients in other countries.
The findings, which one doctor called "provocative," point to an emerging problem in drug development: As research becomes increasingly international, the outcomes may be less dependable in individual countries.
In the new work, researchers drive that point home for drugs known as beta blockers, which gold-standard tests have shown can extend the life of people with heart failure.
Breaking those drug trials down by country, it turns out U.S. patients didn't benefit appreciably, whereas the number of deaths during the trials fell by more than five in 100 in the rest of the world.
Lead researcher Dr. Christopher O'Connor, a cardiologist at Duke University Medical Center in Durham, North Carolina, said earlier studies had hinted of geographical differences in outcomes, but never as clearly as the new results.
Some five million Americans are living with heart failure, in which the heart fails to pump enough blood into the body. The condition is involved in about 300,000 deaths every year, according to the National Institutes of Health.
O'Connor's study, released Monday in the Journal of the American College of Cardiology, represents the first sweeping look at how beta blocker trials may come to different conclusions depending on the nationality of the participants.
He and his colleagues pooled results from so-called randomized controlled trials — the strongest experimental design available to doctors — that included U.S. patients.
They found four trials — the MERIT-HF, the COPERNICUS, the CIBIS-2, and the BEST trials — with a total of some 9,000 participants, nearly half of them American.
During those studies, beta blockers cut deaths among non-U.S. patients by 36 percent, while there was no statistically reliable drop among U.S. patients.
While that doesn't necessarily mean Americans don't benefit at all, it does question heart failure treatment guidelines, which often rely on international trials.
"It raises some concerns," O'Connor told Reuters Health. "If the patients have these differential treatment effects, we have to pay attention to it."
There aren't any clear-cut answers to why the outcomes vary by country.
It could be a question of different use of medications or devices to control heart failure, or it could be a chance finding because only one study included a large proportion of U.S. patients, the researchers write.
O'Connor said genetic differences might also be at play, because African Americans more often harbor a gene variant that makes them less responsive to beta blockers than whites. His study was funded in part by ARCA biopharma, which is developing a genetically targeted beta blocker treatment.
Whatever the explanation for the geographical variation, it's a problem drug developers would do well to tackle if they want their products to be approved by the U.S. Food and Drug Administration, according to O'Connor.
"This really goes beyond the beta blocker and heart failure story, it's about how we conduct clinical trials," he said. "I think the FDA gets nervous when they keep seeing these trends where, things may not look as good in the U.S."
As a case in point, for a while it appeared the FDA might not approve drugmaker AstraZeneca's new blood thinner Brilinta, because North American patients taking the drug did worse than patients on an older blood thinner -- which wasn't the case for European patients in the study.
AstraZeneca finally convinced the FDA the reason for the poorer results in North America might be related to the fact that aspirin interferes with Brilinta, and aspirin is more commonly used by heart patients in the U.S. than in Europe. The FDA approved Brilinta on July 21.
In an editorial in the same journal, Dr. Barry M. Massie, explains that many drug trials have now become "megatrials," including several thousand patients in different countries.
That's partly because current drugs and medical devices are so effective now that most advantages from new treatments will be miniscule. As a result, it requires lots of patients to show that potential benefits aren't just a result of chance.
While Massie, of the VA Medical Center in San Francisco, calls the new findings "provocative," he adds that American patients might still benefit from beta blockers.
"Most important, one cannot exclude the play of chance in these findings," he writes.