Usually, news that an important medicine’s high cost is about to go down would be cause for celebration by doctors, knowing more of their patients would be able to afford it.
But many physicians are wary of what might happen when the blockbuster cholesterol-lowering drugs pravastatin and simvastatin, which go by the brand names Pravachol and Zocor, go off patent in April and June, respectively, and cheaper — probably much cheaper — generic versions become available.
In a recent review Consumer Reports speculated that the cost of these medicines for patients without prescription drug coverage could drop from a daily high of $5 to a low of $1. And insurance co-pays for the generic drugs could fall from a current high of about $75 per month to a low of $5 per month, all resulting in at least tens of thousands more patients taking the drugs than do now.
So what's the concern? Doctors worry that the expected sharp drop in price in the two medicines, both members of a drug class called statins, will make more patients pop the pills rather than try to get at least some of their cholesterol levels down with diet and exercise, a first-step approach endorsed by the government’s National Cholesterol Education Program for people with slightly elevated cholesterol levels but at relatively low risk of a heart attack from other risk factors.
NCEP also recommends diet and exercise as complementary therapy for people at higher risk even if they are started on statin therapy right away because that not only helps to bring down cholesterol levels somewhat, but also reduces other risk factors for heart disease and stroke, such as obesity and high blood pressure, that aren’t helped at all by the statin drugs.
Lifestyle change a tough sell
"One of the concerns we all have is that people will think [these] medicines are the panacea, but diet and exercise are still the cornerstones," says Dr. Roger Blumenthal, director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease in Baltimore, Md. "If you give a person a medication right away, they may not be motivated to make the lifestyle changes."
Maybe not then or ever. Doctors say they have been seeing this time and again over the years with statins, which have been commonly prescribed since the late 1980s. And since then, obesity and inactivity have become even bigger problems.
"Doctors know their patients well enough to worry that once they get an option such as a statin, which can lower cholesterol even without major changes in diet and exercise, it can be hard to convince patients to watch their weight and increase their activity,'' says Dr. Jerry Avorn, an associate professor of medicine at Harvard Medical School and the author of "Powerful Medicines," a recent book about prescription drugs.
Physicians also can contribute to the pop-a-pill mentality when it comes to high cholesterol because they don't always do the best job of emphasizing exercise and diet to their patients, says Dr. Robert Califf, a specialist in cardiovascular medicine at Duke University.
"It’s very time-consuming for doctors to work with their patients on getting them to work on their diets and exercise levels," he says.
Alone, weight loss and exercise can typically bring cholesterol levels down by 5 to 10 percent, which is enough only for people with modest elevations, says Dr. Steven Nissen, interim head of the department of cardiovascular medicine at the Cleveland Clinic in Ohio, who has authored several studies on statin drugs.
People with higher cholesterol levels and other heart risk factors would likely be prescribed a statin immediately, he says.
Still, even a relatively small drop in cholesterol levels thanks to weight loss and exercise is significant. Just a 10 percent decline in every American with elevated cholesterol levels could reduce heart disease in the United States by as much as 30 percent, according to the American Heart Association.
What’s more, losing even a modest amount of weight and adding exercise could bring cholesterol levels low enough to benefit from simvastatin and pravastatin instead of having to opt for more potent but much more expensive statins such as Crestor and Lipitor.
Skipped follow-up tests
Another concern with greater statin use is inadequate follow-up testing. The medications have few side effects but about 1 to 2 percent of people taking them develop liver abnormalities that could lead to liver damage. Periodic blood tests should be done during the first year on the drugs, and then annually, to check for markers that indicate the problem, but many doctors don’t order the follow-up tests.
A more serious but rare side effect is muscle damage called rhabdomyolosis, which was the factor behind the withdrawal of Baycol, a statin drug, in 2001.
Doctors should be asking about muscle weakness, a possible indication of the problem, but too many don’t, says Dr. Sidney Wolfe, head of the Public Citizen Health Research Group, an advocacy organization in Washington, D.C.
About 50 to 100 cases of the muscle condition are reported each year, says Wolfe, and the actual number is likely much higher. If doctors asked about muscle weakness in the early stages of statin treatment, they could lower the dose or stop the drug in affected patients, often before anyone progressed to muscle damage, he says.
Not a cure-all
Perhaps most worrisome is that, over time, people who get great results with statins may not see the need for them anymore, says Avorn.
He says many patients, especially those taking statins preventively with no symptoms of heart disease, stop them after awhile.
That's another reason why lifestyle change is key, even if statin therapy brings down a patient's cholesterol levels, according to Avorn.
"Worst case," he says, "is patients stop the drugs, their doctors are unaware and [those] patients don’t exercise or diet either.’’
Fran Kritz is a health care writer based in Silver Spring, Md.