Ex-Rx?

Over-the-counter status could increase use of cholesterol-lowering drugs. But consumers might be harmed as well as helped.

A decade or so ago, most people hadn’t even heard of statins. Now, it seems, nearly everyone is either taking the cholesterol-lowering drugs or knows someone who is. Propelled by studies showing their ability to reduce blood concentrations of low-density lipoprotein (LDL) cholesterol--the kind most strongly linked with coronary artery disease and stroke--statins have become the top-selling class of drugs in the United States, accounting for $13.5 billion in sales last year. And as evidence of their benefits continues to accumulate--including data showing that they reduce the risk of heart attacks even in healthy people--doctors are encouraging more and more patients to give statins a try.

Still, many people who could benefit from cholesterol-lowering drugs, particularly patients at moderate risk for heart attack and stroke, aren't taking them, says Jerome D. Cohen, a cardiologist at Saint Louis University in Missouri. To increase the use of statins, some doctors advocate making them available without a prescription--a step that could occur within the next year, if the U.S. Food and Drug Administration approves. Experience with other drugs that have made such a switch suggests that the move would encourage statin use, says Cohen. With nicotine patches, for example, the change from prescription to over-the-counter status "really expanded their use," he says. "People didn't go to their docs for a prescription for a nicotine patch, but they did go to the pharmacy." Although selling statins over the counter could make them more available to people who need them, some health professionals worry that patients might use them improperly or that the drugs will end up costing some consumers more than they’re willing to pay.

High cholesterol is a condition without obvious symptoms, so it's not easy to self-treat, says Daniel Streetman, a clinical pharmacist at the University of Michigan, Ann Arbor. And unlike many medicines that are used until the problem goes away, statins are taken daily for years, and their dosage must be adjusted to achieve the target LDL concentration. That tinkering requires regular trips to a physician--a step that people buying their statins off the shelf might skip, says Streetman. "If the general population thinks anything like I do, they would probably miss appointments to have their cholesterol checked or think that because they're on a drug, they don't need to be monitored at all."

One solution would be for pharmacists to offer cholesterol testing. Pharmacy students are now being trained to use machines that crank out cholesterol readings from a drop of blood collected with a single finger stick, says clinical pharmacy professor Karen Kier of Ohio Northern University in Ada. And a couple of states--Florida and Washington--have created a category of medications that can be bought without a prescription but only after consulting with a pharmacist, Kier says. But pharmacists already feel overworked, and no one pays them extra for providing cholesterol screening and counseling, notes Linda Simoni-Wastila, an associate professor of pharmacy at the University of Maryland, Baltimore. "Until you have a health care professional, such as a pharmacist, who is reimbursed for counseling patients on over-the-counter medications, I just don't feel that this rush to bring drugs over the counter is a great idea."

Drug interactions are another area of concern, says Duane Kirking, a professor of pharmacy and public health at the University of Michigan, Ann Arbor. Some statins can interact with a number of other common prescription medicines. Pharmacists filling statin prescriptions routinely review the other drugs a patient is taking, but once products go to nonprescription status, that won't happen, Kirking notes.

Some physicians are concerned about whether the drugs will get to the people who need them. They worry that high-risk patients who need more aggressive cholesterol-lowering therapy might try to self-treat with lower-strength, over-the-counter statins--or that people who don’t really need the drugs might take them "just in case." But drug company studies suggest that won’t happen, says Cohen. Patient education tools--such as Web sites that provide risk assessments based on an individual's cholesterol numbers, personal and family health histories, and diet, smoking, and exercise habits--could help patients decide whether nonprescription statins are right for them, suggests Kier.

Finally, there's cost. Insurance plans usually don't cover nonprescription medications. So even if the price is lower than that of the prescription form of the drug, insured patients who previously coughed up a copayment often end up paying more for the over-the-counter version--at least until competition from other, similar products drives the cost down, says Kirking. Such was the case with the allergy drug Claritin; at roughly $1 per pill, the medicine became considerably more costly for insured patients who'd been paying $10 for a month's supply. Sometimes, patients beg their doctors to switch them to a prescription drug that is covered by their insurance--a move that is discouraged by insurers.

Issues of cost also influence which prescription drugs are covered by insurance, and that can affect how well patients are treated when the medications are not interchangeable. But for most patients, different brands of statins have similar effects, says Richard Pasternak, director of preventive cardiology at Massachusetts General Hospital in Boston. All six statins on the market--Lipitor, Zocor, Crestor, Lescol, Pravachol, and Mevacor (as well as its generic equivalent, lovastatin)--work by the same mechanism, although they differ somewhat in their LDL-lowering abilities at the maximum approved dose, says Streetman. The statins also vary in their side effects and in their tendencies to interact with other drugs, "but not as much as drug companies would like you to think," says Pasternak. "At the end of the day, what matters is that people take statins, not so much which one they take."

What also matters, especially if statins end up jumping across the pharmacy counter, is that patients continue to work closely with their physicians to ensure that they're on the right treatment track, says Cohen. Drug company ads, consumer Web sites, and knowledgeable pharmacists might help patients become more statin-savvy, but "we still want the doctors in the loop." So a statin a day might rein in your cholesterol, but it shouldn't keep the doctor away.

Nancy Ross-Flanigan writes about science and health from Belleville, Michigan, and has a husband who tells complete strangers, "I lowered my cholesterol!"--just like the guy in the ad.