Panorama: Upending the Statin Quo
First published December 2004
Imagine walking into your local drugstore or HMO drug dispensary and picking up a container of cholesterol-lowering statin pills along with your aspirin and sunscreen. Sound farfetched? Not if you live in the United Kingdom, where since last July, customers have been able to buy 5-milligram simvastatin pills off the shelf.
The new program -- the brainchild of the UK's National Health Service (NHS) -- is intended to change the face of preventive cardiology by putting a low-dose cholesterol-lowering drug directly into the hands of many whose coronary heart disease risk might otherwise go unnoticed and unattended. Indeed, by recommending that all men aged 55 and over -- and both men and women between 45 and 54 considered at moderate risk -- indulge daily, they are hoping to prevent or at least delay by years, thousands of heart "episodes."
In January, two Food and Drug Administration expert committees reject-ed a similar proposal for American consumers, citing concerns for patient safety. UCSF clinical pharmacist and cardiology drug expert Steve Kayser and cardiologist Michael Crawford -- while agreeing that statins have proven their worth in lowering the risk of heart disease -- share the panel's concerns. In short, given the American addiction to the quick health fix, they wonder if a public policy intended to prevent disease might boomerang instead.
"People might think that by taking a pill, they can ignore the lifestyle changes, like an improved diet and regular exercise, they also need to make. Or they may decide to triple the dose in the mistaken belief that the more they take, the lower their cholesterol readings will be," says Kayser. Crawford agrees. "I worry about the health attitude of most Americans. They won't do the simple things like eating more fruits and vegetables, and this could encourage them to be even more lax. As it is, I'm always being asked by patients, ‘If I take this pill, can I eat anything I want?'" And while neither worries that potential side effects, including muscle weakness and liver damage, trump the benefits of statin therapy (particularly when OTC pills are half the prescription drugs' potency), they worry that these benefits may have been overstated. Studies demonstrate, for example, that patients are more likely to break bad habits and substitute healthier ones -- including taking a statin pill every day -- if they are part of a support group. "Compliance always drops off after about six months," explains Kayser, which is precisely when the drugs begin to work best.
No such support groups are a required part of the UK program, although guidelines governing everything from coordinating care with physicians to estimating individual risk have been issued by the Royal Pharmaceutical Society of Great Britain. There is a fallback position as well. Pharmacists are not required to sell statin to anyone under the age of 55, or over that age either. Customers must first consult with a pharmacist about such risk factors as smoking, family history of heart disease, ethnicity (South Asians, for example, are at higher risk for heart disease) and weight. Potential drug interactions also are discussed. Those at high risk are then referred to the care of physicians, as are those with a previous heart attack or stroke, diabetes, hypertension and other symptomatic health problems.
Public health advocates in the UK have high hopes for this pharmacist-managed screening process, and when Kayser envisions a similar system of pharmacy-driven care in the US, he warms to the idea -- with one caveat. "I approve of pharmacists taking a leader-ship role, but they should be reimbursed for it," he says.
Not surprisingly, Crawford has a slightly different take. "As a cardiologist, I already spend a lot of time talking to people. How important that is in the grand scheme of things, I'm not sure, but I'm also not sure if we want pharmacists doing medicine, particularly since most pharmacies are not really set up for effective counseling." For now, the kind of follow-up routinely performed, liver enzyme tests being just one example, is directed by a physician. Kayser worries about follow-up, too, albeit a different variety. "There's no way to know if the UK approach will work if there aren't well-controlled studies. I assume there will be some, so right now we're all just guessing."
Guessing, of course, is what some in the UK have condemned. In their view, this is an uncontrolled experiment on humans, driven, in part, by the NHS's desire to pass the costs of therapy on to consumers and a pharmaceutical company's eagerness to wring new profit from an old drug before it goes off patent. Still, it seems that some in the UK are way past the guessing stage. With over-the-counter statin therapy now a reality, they have moved on to the next target: statin-fortified drinking water. Gulp.