statinsandthe mediterraneandiet

Statins and the Mediterranean Diet

One might reasonably expect the U.S. government’s cholesterol-treatment guidelines to be firmly based on scientific evidence. Certainly, that was the claim of the National Cholesterol Education Program when it issued an updated report in 2004. What alarmed some researchers and consumer advocates at the time was the expansion of statin use to include people who do not have heart disease but are supposedly at “moderately elevated risk” for developing it.

The updated guidelines would put an additional 23 million Americans on statins for the rest of their lives. A cloud of doubt hung over the entire issue once it became known that the majority of physicians who established the guidelines had financial ties to companies that make statin drugs.

Statins, the top-selling class of drugs in history, are cholesterol-lowering drugs that include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol), simvastatin (Zocor) and rosuvastatin (Crestor). Their benefit to people with heart disease is proven, but there is a controversy regarding the use of these drugs by everyone else. Three-quarters of all Americans now on long-term statin therapy do not have heart disease.

In a recent issue of the medical journal, Lancet, John Abramson, MD, Harvard Medical School, and James Wright, MD, University of British Columbia, Vancouver, co-authored a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?” They conducted an analysis of all the major trials in which participants were randomly assigned to take either a statin or a placebo. The seven trials that included adults between 30 and 80 years old who already have heart disease clearly showed that statins lower the risk of a cardiac death as well as a death from any cause.

However, their analysis of the other trials that included healthy but high-risk people without heart disease showed that statins should not be prescribed to women of any age who do not have heart disease or diabetes, or to men older than 69 years who do not have heart disease or diabetes because no benefit was shown for them.

There is a modest benefit for men aged 30-69 years who are at high risk of developing heart disease. Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event” —that is, a heart attack or heart-related death. Put another way, out of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction for no benefit. “In our experience,” wrote Drs. Abramson and Wright, “many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall benefit health.”

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What follows is an interview with the lead author of this analysis, John Abramson, MD, who is also the author of the 2004 book entitled, “Overdosed America” and serves as an expert consultant to plaintiffs’ attorneys in litigation involving the drug industry including Pfizer and Lipitor. He is interviewed by Maryann Napoli.

MN: Whenever I write about statins, I get calls from readers that indicate many are misled about their level of risk. Typical is the healthy woman over the age of 65 pressured to take statins by her doctor who says that she is at high risk for a heart attack solely because of age and high cholesterol.

JA: 1) The evidence shows that the higher her cholesterol, the longer she will live; 2) no trial shows that statin therapy will benefit her; 3) people over 65 who exercise routinely, eat a Mediterranean-style diet, don’t smoke, drink moderately, will have a 60% lower rate of death than the people who don’t do these things.

MN: That one trial with people over 70, called PROSPER (PROspective Study of Pravastatin in Elderly at Risk), is often misrepresented.

JA: This trial clearly showed the limited benefit of statins in the elderly. For those who already have cardiovascular disease, taking a statin reduces the risk of heart attack or cardiac death. But it also showed that people in this age range who are at increased risk of, but do not have, cardiovascular disease do not benefit from taking a statin. Importantly, the study also found that at four years, there was one extra new cancer for every 70 people taking a statin. No reduced risk of stroke and no benefit for people without cardiovascular disease and an increased risk of cancer, yet millions of elderly Americans without heart disease or diabetes are taking these drugs because they and their doctors are misled into believing that clinical trials have shown that statins are beneficial.

MN: And people who have had a heart attack?

JA: Statins are definitely helpful for people who have already had a heart attack. Still, the Lyon Diet Heart Study shows how much more effective a healthy diet is in reducing the risk of heart attack for these folks. The participants were randomly assigned to receive counseling about a Mediterranean-style diet (see end of article) or a standard post-heart attack diet. Those who went on the Mediterranean-style diet developed 72% less heart disease than those in the control group. There was also a 56% lower death rate and 61% less cancer than the people in the control group. Simply eating a Mediterranean-style diet is nearly three times more effective at preventing recurrent heart disease and death in post-heart attack patients than is taking a statin. Even more surprising, those on the Mediterranean-style diet did not have lower cholesterol than those eating the standard post-heart attack diet. So when your doctor tells you to get your cholesterol down…keep that in mind.

MN: Lifestyle changes aren’t given much attention.

JA: The vast majority of communication about heart disease is influenced by the drug companies. They focus on cholesterol, rather than diet, exercise, and not smoking because their primary responsibility is to maximize the financial return to their investors, and that’s where the money is. All but one of the major statin trials was funded by a company that makes statins.

MN: That should make us all wary—studies show that the majority of drug company-funded studies produce results favorable to their product.

JA: The ALLHAT [Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial] was the only one of the 14 major statin trials included in the most recent review [published in the Lancet in October 2005] not funded by a drug company. It included a good mix of people: men and women with and without heart disease and/or diabetes. Half of the participants were randomly assigned to be treated with a statin and half to go to their regular doctor and do whatever he or she thought was right. By the end of the study, 26% of the people assigned to “usual care” had been put on a statin by their doctors and 77% of those in the statin group were still taking the statin (the others discontinued because of side effects, other medical conditions, etc.). But the results showed that there was no less heart disease or death in the group with three times as many people taking statins.

MN: These results seem to be widely misperceived.

JA: One of the reasons is a misleading editorial that accompanied the publication of ALLHAT in the Journal of the American Medical Association. It stated: “Physicians might be tempted to conclude that this large study demonstrates that statins do not work; however, it is well known that they do.” That’s not quite what I think of as evidence-based medicine. The editorialist actually had the chutzpah to suggest that statins may be less effective when they are prescribed by primary care physicians, as they were in the ALLHAT, than by cardiologists. At the time of the editorial, the writer had financial relationships with at least seven drug companies. He is now employed by Merck, which makes Zocor.

MN: All but two of the statin trials failed to report their serious adverse events, defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, requires prolongation of hospitalization, or results in significant disability.

JA: The statin trials that report only the drug’s effects on heart disease are not presenting what we all really need to know. The most important question is: What is the overall effect of taking the drug? In other words, if a statin decreases the risk of heart disease but does not reduce the overall risk of serious illness or death unrelated to heart disease, is it worth taking? And the difficulty of answering this question ought to lead people to wonder if there are alternative ways to reduce the risk of heart disease.

MN: Why do journals allow drug companies to publish only heart-related results of their trials?

JA: Medical journals are not fulfilling their responsibilities when they publish trial results and omit all serious adverse events and deaths from all causes.

MN: Any parting thoughts?

JA: People ask, “Why can’t I just take a pill, eat what I want and forget about going to the gym?” And I say to them: If the pill worked, that would be a good question, but there just isn’t any evidence from clinical trials showing that statins are beneficial for women or older men who don’t already have heart disease or diabetes. Healthy lifestyle changes are a more effective, less expensive, and safer way to reduce your risk of heart disease and improve your chances of staying healthy overall.

For information on the Mediterranean-style diet: go to www.americanheart.org and type into the search box: Lyon Diet Heart Study.

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