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In an era of escalating medical costs, the overuse of drugs gets a lot of attention. We do have many examples where there seems to be an irrational exuberance for drugs that have yet to prove their worth. But a careful look at medical practice reveals that we also have a problem with underuse of effective therapies.
A study out this week in JAMA, one of the top medical journals, provides new perspective on the underuse of medical therapy. The story starts a little more than 4 years ago when a large, government-funded study called COURAGE showed that for patients with stable blockages in their heart arteries, a regimen of medical therapy that included 3 basic medications that are available as generics (aspirin, a beta-blocker and a statin) produced the same long-term results as percutaneous coronary intervention (PCI), a procedure to open the blockages. The groups were similar in the risk of death and heart attack. And there were no major differences in their quality of life.
How is this possible? For years doctors assumed that opening a blockage would benefit patients with stable disease. We do know it helps patients who are experiencing a heart attack - and in that setting can be lifesaving. We thought that if we could make the arteries look better, that patients would benefit. It turns out in COURAGE that the procedure to open blocked arteries offered no protection against heart attacks and death.
The message in the COURAGE study was that patients and their doctors would not lose anything by having the courage to resist immediate referral for a procedure. COURAGE was not the only study to fail to find an advantage of PCI in this patient population. Several other studies showed that medical therapy could produce the same results as the procedure. No major study showed that PCI was superior for patients who are stable, meaning that their condition is not worsening. There were critics of COURAGE when it was published - but few are disputing the findings now.
The findings from COURAGE led to a recommendation that patients be tried on medical therapy before proceeding to a procedure, which has its own set of risks. The idea is that patients who do well with the simple, inexpensive medical regimen could avoid a procedure and get the same results.
The JAMA study examined how patients around the country are being treated before undergoing a PCI for stable heart disease. They found that fewer than half of the patients were on this regimen before having the procedure. Moreover, there has been no increase in the use of the medical regimen since the publication of COURAGE. And, in case you were wondering, they counted patients as on the regimen if they took the medications for which they did not have a contraindication. So the low percentage was not a result of people not tolerating the medications.
In choosing whether to have a procedure, there are many considerations. Not everyone wants to take medications. Some patients would prefer to have the procedure over the choice of adding medications to their regimen. Some patients may think that the results of the studies do not apply to them.
Here is my question...is the low use of medications before the procedure the result of patient preference? Did the patients know that they were not on an optimal medical regimen when they were referred for the procedure? Did they know that studies show that patients treated with an optimal medical regimen have the same results as those treated with the procedure? Did they know that the procedure does not reduce the risk of death or a heart attack - or even substantively reduce symptoms compared with optimal medical therapy used in COURAGE?
Unfortunately, studies indicate that patients undergoing these procedures often do not understand the evidence. They most often assume that opening the blockages will reduce their risk. They make the connection between better-looking arteries with better outcomes. It is a reasonable assumption until you review the evidence. The bottom line is that patients are commonly undergoing these procedures with unrealistic expectations of what it will do for them.
The report of the underuse of medical therapy in patients referred for procedures challenges us to be sure that informed choices are being made by patients. If they are the ones eschewing the medicines, then we can defer to their preferences. But if this finding represents the results of an impatient medical care system that finds it more expedient to refer for procedures than treat with effective medical and lifestyle interventions, then we have some work to do.
Too often our health care system does too much of one thing and not enough of another - and the patients are not driving the choices. Finding the approach that's 'just right' will require us to ensure we connect evidence with patient preference and produce truly informed choice.
Harlan Krumholz is a cardiologist at Yale University.
