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Whenever researchers compare drugs or treatments to see which works best, somebody's ox gets gored. Such "comparative effectiveness" studies have already cast doubt on expensive new blood pressure and schizophrenia drugs, as well as spinal fusions and other surgeries. And the latest case involves a very expensive ox: a heart procedure known as angioplasty.
Each year, more than 1.3 million Americans have their clogged arteries widened with a tiny balloon and then kept open with slender mesh tubes called
, made by companies like Johnson & Johnson ( (JNJ)
) and Boston Scientific ( (BSX)
). The total bill for these angioplasties is more than $21 billion a year. But while many patients and doctors firmly believe that angioplasties prevent heart attacks, the data say otherwise. A series of studies—the newest published in the June 11 issue of The New England Journal of Medicine—finds that stable patients with chronic heart disease who have the procedure get little benefit compared with similar patients treated just with drugs, such as Pfizer's ( (PFE)
) cholesterol-lowering Lipitor and other statins, and aspirin. "There are still many patients who undergo angioplasty without really understanding that it will not reduce chances of heart attacks or death—though it will reduce symptoms," says Dr. Judith S. Hochman, director of the Cardiovascular Clinical Research Center at the New York University School of Medicine.
That's why there's a growing effort, led by physicians,
, and even state legislatures, to make sure patients truly understand the medical evidence about angioplasty and other treatments and procedures. Once informed, the patients are encouraged to make their own choices. This idea goes by the somewhat clunky name of shared, or informed, decision-making. Instead of being routinely whisked in for a prostate screening PSA test, for instance, men would first be told that major studies have failed to show the test saves lives. What's more, the test increases the chances a patient will undergo surgery or treatments that cause incontinence, impotence, and other problems. "The fact that PSA screening is more likely to cause mischief than save a life is not intuitive to patients or even physicians," says Dr. Paul J. Wallace, medical director for health and productivity management programs at health-care provider Kaiser Permanente, which is testing this approach.
Studies show this process, using comprehensive videos and other materials prepared by groups such as the nonprofit Foundation for Informed Medical Decision Making (FIMDM), leads patients to choose conservative options more often. It reduces rates of angioplasty or prostate surgery, for instance, by 15% to 30%. Put into widespread use, the approach has the potential to trim hundreds of billions of dollars from the nation's $2.4 trillion health-care bill. Yet patients do as well or better than if they had opted for the procedures. Surveys done after the decision also show patients to be more satisfied, no matter which choice they made. "That's the kind of win that doesn't fall into your lap very often," says Washington State Senator Cheryl Pflug, a Republican.
A nurse and health-reform advocate, Pflug two years ago pushed through the nation's first law encouraging the use of informed decision-making. One prod to action was seeing the wide variation in the rates of procedures in the state of Washington, suggesting that some patients were being overtreated. Another was a sobering medical experience in the family of one of Pflug's staffers. The staffer's 90-year-old mother could no longer use her right arm after a stroke, though she was still able to live independently. Then a lump was discovered in her breast. Her doctor wanted to do a radical mastectomy, saying it could add 20 years to her life. And, on top of that dubious assessment, he failed to inform the mother that surgery might cost her the use of her remaining arm. After the staffer dug up this information, her mother said no to the surgery.
In today's health-care system, such sharing of evidence is rare—and financial incentives are heavily skewed toward doing more surgeries and other procedures, not fewer. Doctors and hospitals get hefty paychecks for interventions but not for spending the time needed to discuss the full evidence with patients. "The payment system is upside down. To get paid more for doing more is not the right answer," says Dr. James N. Weinstein, chair of orthopedic surgery at the Dartmouth-Hitchcock Medical Center.
Often, specialists tune out facts that challenge their cherished beliefs about the benefits of what they do, says Dr. Albert G. Mulley, professor of medicine and health-care policy at Massachusetts General Hospital. "Urologists love the sense of heroism they feel when they 'save' men from prostate cancer," Mulley says. "What they forget is that 97% of men die of something else and that the evidence supports the skeptics."
An analysis by Mulley shows these misconceptions skew even the scientific view of disease. Once physicians acquired the ability to prop open or bypass clogged arteries, those narrowed arteries came to be seen as the main cause of heart attacks. Yet there had always been evidence for a different cause: unstable plaque in arteries that ruptures, leading to dangerous or fatal clots. Now that studies are showing stents and bypass surgery usually don't prevent heart attacks or death, the unstable plaque theory is making a comeback. But the message isn't getting out. In focus groups with patients, "I have yet to find anyone who thought there was any choice," says FIMDM president Floyd J. Fowler Jr. "They all think that the angioplasty or bypass operation saved their lives. It's astounding how distorted people's perceptions are."
To combat this problem, Dartmouth's Weinstein shunted doctors aside when he created the first shared-decision-making center a decade ago. Just as patients go to a separate lab to have blood drawn, they go to a nearby facility at Weinstein's spine center to see an FIMDM video and have a chance to talk about their concerns. For patients with herniated discs, the video explains that outcomes are about the same whether they have surgery or not. Once the program started, rates of spinal surgery at Dartmouth, already lower than the national average, dropped 30%.
Health insurers are implementing similar strategies. Pennsylvania's Highmark tries to contact patients when a claim comes in for an MRI for back pain, showing that they may be facing a choice. "We may send a card saying, 'Do you know you can call in for materials?'" says Chief Medical Officer Dr. Donald R. Fischer. HealthPartners in Minnesota has started to require that patients get authorization—and be offered a shared decision-making experience—before undergoing spinal fusion. In California, Health Net ( (HNT)
) uses automated calls to reach people with chronic conditions, offering the chance to talk to a health coach or nurse, who then tells patients they can download decision-making videos to their computers. Some 20,000 patients have participated, and "the incidence of elective procedures has been decreasing," says Health Net's chief medical officer, Dr. Jonathan H. Scheff. "The cool thing is that this is not about saying 'no.'"
So far, these efforts reach only a tiny percentage of patients. When FIMDM was set up in 1989, "we totally minimized the difficulty of getting this used," says Massachusetts General's Mulley. One reason is that people are naturally suspicious of information from insurers or employers. "The tension in this is whether it is just another way to talk patients out of something expensive," says Kaiser's Wallace.
Dr. Donald S. Baim, chief medical and scientific officer at Boston Scientific, notes that reducing chest pain is a major benefit of angioplasty. Still, "there are patients receiving angioplasty where clearly they can be as well treated" with drugs, says Dr. Ralph G. Brindis, president-elect of the American College of Cardiology.
There's another obstacle in getting information out: It's hard to reach patients before they've seen their specialists and gotten a perhaps incomplete picture of the risks and benefits of a procedure. That problem is particularly acute with angioplasty, because patients are typically whisked in for the procedure immediately after having diagnostic tests.
To get more information to patients, advocates are pushing to change the incentives in the health-care system. The Washington State law, for instance, mandates demonstration projects in shared decision-making and raises malpractice protections for doctors who use the approach. Other ideas include adding reimbursements for the decision-making process itself or paying a flat rate for an episode of, say, back pain, regardless of the treatment. The potential of these steps to reduce overuse of procedures—and cut costs—is huge. Overall, "there is good reason to believe 30% to 40% of what we are spending goes for unnecessary services and inefficient care," says Dr. Elliott S. Fisher, professor of medicine and director of the Center for Health Policy Research at Dartmouth Medical School.
The field is also expected to get a boost from new comparative effectiveness research. Despite objections from drug and medical-device makers, which fear their oxen may be next, the Obama Administration is pumping $1.1 billion into trials that will compare treatments. "We're at a tipping point," says Dartmouth's Weinstein. "When patients are well informed, they make different decisions. If they really don't want interventions like surgery, and the outcomes are the same or better, why not do this?"
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In two related reports, the CBS Evening News with Katie Couric explores the limited clinical benefits of angioplasty and efforts to explain the evidence clearly to patients.
For these and other stories go to http://bx.businessweek.com/comparative-effectiveness/.