No doubt you’ve seen the headlines announcing—or denouncing—the new guidelines on cholesterol control that could, if implemented, double the number of Americans who take cholesterol-lowering statin drugs. By some estimates, nearly one in three of us might soon be popping statin pills every day.

This is a very big deal. Proponents claim that the new guidelines from the American Heart Association and the American College of Cardiology will save many more patients from potentially fatal heart attacks and strokes. Critics say that the new guidelines are seriously flawed, in part because the calculations on which they’re based are faulty—and thus statins will be pushed on people who don’t need the drugs, putting them at risk for serious side effects.

No wonder people are confused!

Many doctors will blindly follow the new guidelines, I suspect. So, to discuss the guidelines’ effects and implications, I contacted someone I trust on this complex subject—John Abramson, MD, a lecturer of health-care policy at Harvard Medical School and author of Overdosed America: The Broken Promise of American Medicine. He told me that, in some ways, the new guidelines are an improvement over the old ones—but they also contain some serious flaws that could put a lot of people in jeopardy.

Here’s what we all need to know to stay safe…

GUIDELINES IN A NUTSHELL

First, let’s clarify just what the new guidelines are calling for. Statin drugs reduce low-density lipoprotein (LDL), also known as “bad” cholesterol, and they can reduce the risk for heart attack and stroke in certain people. The new guidelines, aiming to help exactly those people, recommend statin therapy for anyone who…

  • Is between the ages of 40 and 75 and who has type 1 or type 2 diabetes.
  • Has a history of heart disease, peripheral artery disease, angina, arterial revascularization (bypass or angioplasty), stroke or transient ischemic attack (TIA or “mini stroke”).
  • Is over age 21 and has an LDL level of 190 milligrams per deciliter (mg/dL) or higher.
  • Is 40 to 75 years old and, according to a new “risk calculator,” has a 7.5% or higher risk of having a heart attack or stroke within 10 years.

It’s primarily this last category that is causing the raised eyebrows (and raised voices)—because if everyone who fit into it adhered to the guidelines, a staggering number of new statin prescriptions would be written, Dr. Abramson said. But would it save lives? That’s the big question.

Let’s look at the pros and cons of the new guidelines…

WHERE THE NEW GUIDELINES ARE GOOD

Dr. Abramson pointed out several ways in which the new guidelines are an improvement over the older, most commonly used guidelines from 2002…

The new risk calculation considers stroke and other non-heart-attack risks. Rather than focusing on only heart attack, the new risk calculator takes into account the risk for any “atherosclerotic event”—including heart attack, stroke and peripheral artery disease.

The LDL targets are vastly simplified. The old guidelines recommended statins based on a rather complicated matrix of LDL pretreatment numbers and specific goal numbers, with those numbers varying depending on a patient’s risk factors. For instance, at the high-risk end of the “statin spectrum” was the person with heart disease, who would get statins if his LDL was 130 or higher…and the goal was to get his LDL down below 100 or even 70 if he was at very high risk. At the low-risk end of the spectrum was the person without heart disease and just one or even zero risk factors, for whom statins would be recommended at an LDL of 190 or considered as an option at an LDL of 160 to 189…with a goal of getting his LDL down below 160.

The new guidelines are much less convoluted, simply recommending that statins be given when LDL is 190 or higher—because experts generally agree that 190 is too high. The new approach also abandons the goal of reaching some “magic” LDL number (such as 100 or 70)—because those goal numbers turned out to be random.

In addition, the new guidelines would keep a small group of patients off of statins, Dr. Abramson pointed out—the group at the low-risk end of the spectrum whose LDL was already below 190, who had zero or one risk factors, and who (under the old guidelines) would be taking statins only to lower their LDL. For these people, the new guidelines would take them off statins.

The effects of ethnicity are included in the risk calculation. Previously, risk assessment was based on data from studies of mostly non-Hispanic white men and women—but whites do not carry the same risks as people of other ethnicities. Now, the 10-year risk is calculated based on data from several large population studies that included African Americans, so separate risk assessments can be made for black and white men and women. This is a step in the right direction in terms of calculating risk.

There still is more work to be done in this area, however, given that other ethnic groups are underrepresented in studies and so are not yet specifically included in the risk equation. The guideline authors acknowledge that risk generally is lower in Hispanic-Americans and Asian-Americans and higher in Native Americans—and they admit that the lack of ethnicity-specific algorithms is a definite gap. For now: Patients and doctors should take into account the fact that the risk calculator may overestimate risk for people of Hispanic and Asian descent, Dr. Abramson said.

WHERE THE PROBLEMS LIE

Now for the bad news. The new guidelines are generating serious concerns, Dr. Abramson said, based on the following problems…

The risk calculator’s accuracy is in question. The 2002 guidelines recommended statins for people who, based on the old risk calculator (called the Framingham risk score), had a 10% or higher risk of developing coronary heart disease within 10 years…who had two cardiovascular risk factors…and who had an LDL of 130 mg/dL or greater.

The new risk assessment involves a complex calculation that assigns values to various factors—including sex, age, race, total cholesterol, high-density “good” cholesterol, systolic blood pressure (the top number of a blood pressure reading), diabetes and smoking history. This yields a risk score, expressed as a percentage, that estimates the likelihood of experiencing a heart attack, stroke or other cardiac event within the next 10 years. A risk of 7.5% or higher, according to the new guidelines, merits statin therapy.

But (and this is a big but!): Many experts question the validity of this new risk calculator itself, saying that in some cases its results are deceptive or even flat-out wrong. Some prominent cardiologists—including the past president of the American College of Cardiology, Steven Nissen, MD, of the Cleveland Clinic—have publicly stated that the formula used in the risk calculation can dramatically overestimate a patient’s risk for heart attack or stroke. That’s because the studies used in determining risk are from the 1990s, when more people smoked and had cardiovascular problems at younger ages. Based on more recent clinical studies, they say, a person’s true risk is lower than what is cranked out by the new calculator—by as much as 150%! In other words, the new calculator would have all sorts of people start taking statins who don’t actually need them.

At the same time, the risk calculator fails to take into account the influence of family history—in fact, the guideline authors acknowledge that the calculator was not designed to be used with patients who have a family history of high cholesterol! This is a very odd oversight, given that genetic factors play a significant role in heart health.

In many cases, there’s no net benefit in terms of lives saved—yet the risks of statins can be serious. Based on his research, Dr. Abramson said, “These new guidelines are going to expand the number of healthy people for whom statins are recommended. If statins would help their health, that would be a good thing…but that’s not what the evidence shows.”

Dr. Abramson and colleagues evaluated data from a meta-analysis comprising 27 clinical trials studying the effects of statins. They found that, for people who have less than a 20% risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness. “We showed that, based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke. Yet there would be no overall net reduction in death or serious illness because the person who would have had the heart attack or stroke without statins is likely to die of some other cause during the same timeframe even if he is taking statins,” Dr. Abramson said.

At the same time, 18% or more of this group would experience side effects from taking statins, such as muscle pain or weakness, decreased cognitive function, liver damage, kidney damage, sexual dysfunction and/or increased risk for diabetes (especially for women). According to Dr. Abramson, clinical trials tend to underestimate the frequency of statin-related adverse events—and the authors of the new guidelines glossed over these side effects. “They were very narrowly focused on reduction in cardiovascular risk rather than the overall effect on the person,” he said.

High-dose statin therapy is overused. Under the new guidelines, high-dose statin therapy, which aims to reduce LDL by at least 50%, is recommended for people with a history of heart disease or stroke and for those with LDL above 190. Moderate-dose statin therapy is recommended for most of the others who would be prescribed statin drugs.

An example of a high-dose statin therapy is 40 milligrams (mg) to 80 mg of atorvastatin (Lipitor). Research shows that a high dosage is linked to very significantly increased risk for diabetes. The new guidelines would have far too many people taking such dangerously high doses of statins, Dr. Abramson said.

The importance of lifestyle is underemphasized. Another problem is that, by taking statins, people at risk for heart disease may think that they’re well-protected by their pills and therefore feel less motivated to take the action that could reduce their risk for heart disease by an impressive 80%—which is to improve their lifestyle. “Statins give the illusion of protection to many people who would be better served, for example, simply by walking an extra 10 minutes per day,” Dr. Abramson said.

Proponents of the new guidelines point out that the very first recommendation listed is to make lifestyle modifications, such as following a healthy diet, getting regular exercise, maintaining a healthy weight and not smoking. These are recognized in the guidelines as critical components of risk reduction that must be emphasized both before a person tries statins and when a person does take statins.

However, critics of the new guidelines are concerned that the importance of lifestyle is glossed over. For instance, according to Dr. Abramson, the guidelines merely pay “lip service” to lifestyle modifications while focusing the overwhelming majority of their recommendations on high-dose statin therapy—despite the guideline authors’ admission that reducing cholesterol with drugs may not have the same beneficial effect as reducing cholesterol with diet and exercise.

Whether health-care providers and the public will hear the guidelines’ understated message about lifestyle over the din of advertisements from statin manufacturers remains to be seen.

Money may still be exerting its influence. Although the authors of the new guidelines have publicly disclosed their past and present relationships with pharmaceutical companies, if any, Dr. Abramson said that the group “was not sufficiently free of conflicts of interest” because several of the experts on the panel have recent or current financial ties to drugmakers. In addition, he said, both the American Heart Association and the American College of Cardiology, while nonprofit entities, are partially supported by drug companies.

Such influence also affects the underlying research. “Most statin studies have been funded by pharmaceutical companies, which design studies that will produce results that are going to sell drugs,” Dr. Abramson said. In other words, the statin studies upon which the new guidelines are based were influenced by the very same companies that stand to benefit from increased sales.

It could be argued that money is less of a motivating factor now that all statins except rosuvastatin (Crestor) are available in generic forms, meaning that pharmaceutical companies don’t stand to profit all that much from any big jump in sales. Also, the new guidelines expressly state that statins—rather than ezetimibe (Zetia), a different type of cholesterol-lowering drug that has not yet gone generic—should be used to reduce cardiovascular risk. For those reasons, proponents of the new guidelines say that Big Pharma isn’t expecting any windfall…

Or is it? As Dr. Abramson explained it, history has shown that newer classes of drugs tend to emerge and replace others, even if the old (and cheaper) classics work fine. Eventually, new drugs will take the place of statin medications, and these guidelines will become defunct. Until then, he said, these guidelines maintain interest in pills—rather than a healthy lifestyle—to reduce cardiovascular risk.

BOTTOM LINE: GUIDELINES ARE NOT MANDATES

Remember that guidelines are issued in an attempt to meet the needs of patients in most circumstances, and they are not intended to replace the judgment of your health-care provider. The final choice always rests with you and your doctor.

If your physician suggests that you take a statin, before you make your decision, have an in-depth conversation about the benefits and risks as they apply to you individually…discuss the concerns outlined above…do a careful review of your family’s heart-health history…and get serious about reducing your risk by adopting a healthier lifestyle.