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Doctors also worry about harmful interactions with drugs heart patients may already be taking, including other cholesterol-lowering drugs, anticoagulants, antifungals, and even common antibiotics. This could be a bigger problem in the United States than in Britain, where simvastatin will actually be sold in a special class of over-the-counter drugs for which pharmacists act as gatekeepers. Although a cholesterol test will not be required, patients will have to answer questions to allow pharmacists to determine their risk of coronary heart disease, as well as what other drugs they are taking. But the advent of such a system doesnt seem likely in the United States. There is a small fee for pharmacist counseling in Britain, and U.S. patients wont want to pay for it, says Peter Jones, codirector of the Lipid Metabolism and Atherosclerosis Clinic at Baylor College of Medicine in Houston. If Ive got a $10 copay to see my doctor, why should I pay $10 for the pharmacist to tell me this when I maybe trust my doctor better? he asks. I dont think the U.S. is ready to have that tier.

Still, most experts feel that risks of adverse effects are small. Of more concern is that patients will lose the chance for more comprehensive counseling from their doctors on risk factors such as diet, exercise, weight, and smoking. “Some people feel that taking a Lipitor [statin] and eating a Big Mac at the same time is somehow going to offset one another,” says Cohen. “And you wouldn’t want that to happen on a large scale.”

Perhaps the major objection of British doctors, though, is cost, says Cohen. About 1.8 million Britons currently have prescriptions for statins, costing the National Health Service more than $1.2 billion a year; that figure is predicted to grow to more than $3.6 billion a year by 2010. Doctors worry that many patients who currently receive the drugs for free will be unable to afford the predicted monthly cost of roughly $18 to $27 for a drug usually taken for years.

Even in the United States, where most patients already pay for at least part of their prescriptions, cost could be a problem, according to Cohen. These are daily medications, he says. It can be anywhere between $20 and $60 a month or more, maybe $100 a month. Insurance companies might follow the model seen recently with allergy medications, taking newer, more expensive statins off the list of covered drugs if an older statin becomes available over the counterin effect, shifting the cost of the drugs to consumers.

But despite the risks and costs, many believe over-the-counter statin sales would have benefits in helping to prevent coronary heart disease. Wider availability of the drugs could, for instance, help shift consumer spending away from nutraceuticals, over-the-counter supplements with questionable health benefits. Says Jones: There are people who would spend the same amount of money as you can spend on a statin taking garlic pills, which do absolutely nothing.

Allowing over-the-counter sales of statin drugs could increase their use, ultimately helping a huge number of people. Anyone with risk beyond the most trivial level will, somewhere around the age of 50 or 60, see the benefit of a statin far outweigh the risks, says cardiologist Richard A. Stein, associate chair of medicine at the Singer Hospital of Beth Israel Medical Center in New York and a spokesperson for the American Heart Association. Less than one-third of Americans with elevated cholesterol are being treated, according to the association. The current model is leaving untouched and at high risk a substantial amount of our population, Stein says. Buying a statin drug in the drug store isnt a good alternative to seeing a physician, Stein emphasizes. But he believes that there are large numbers of people who dont get into the medical system and whose risk of heart disease and heart attack would be reduced if they took the pill. Since its the major cause of death and disability in the United States, a 10 percent reduction in that risk is extraordinary in terms of its health care implications.

An FDA decision to give statins over-the-counter status in the United States could come within the yearor not for several years. In the meantime, experts say, theyll be closely watching how things go on the other side of the Atlantic. In Britain well have a nice test model, says Stein. Well be able to look at, five years down the road, how widely its used, whats happening to the overall risk of heart attacks, and well have a very nice model to see if it works. To their benefit or not, it seems that British consumers will indeed be serving as test subjects in a massive medical experiment.

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