I am in complete agreement with my colleagues, Doctors Karen E. Aspry and Charles B. Eaton, on the importance of shared decision making when it comes to placing patients without established heart disease on statins. Their Feb. 18 Commentary piece “Fight heart disease with shared decisions about statins” has much to commend it.
Where we differ is in what we believe about the new statin guidelines, which were released last November by the American Heart Association (AHA) and the American College of Cardiology (ACC).
There are serious problems with the guidelines, as well as with the clinical trials on which they are based. The majority of the physicians/scientists who wrote the guidelines, including both of the co-chairs, had current or recent ties to the pharmaceutical companies that manufacture statins. In other words, they had conflicts of interest.
The recommendations for putting people on statins were based on clinical trials comparing statins to a dummy drug, called a placebo. These trials were paid for by the drug companies that made the statin being studied. In an article published in the Journal of the American Medical Association in 2003, industry-sponsored trials were found to be almost four times more likely to show a “positive” result for the drug being studied than non-industry sponsored trials.
The AHA and the ACC acknowledged that the new risk calculator that doctors were told to use to determine the risk of heart disease in healthy patients overestimates risk by anywhere from 75 percent to 150 percent. Abiding by these recommendations could add 13 million healthy people to the number already taking statins in the United States. And despite the reassuring words about the safety of statins from Doctors Aspry and. Eaton, statins are far more dangerous than clinical trials indicate. Why is this?
Most clinical trials exclude patients with other chronic diseases, or certain age groups. They are also of limited duration. The largest statin trial in healthy people was stopped after an average follow-up of just under two years. And yet people are being told they must take a statin for life.
In addition, some statin trials had run-in phases, in which anyone who couldn’t tolerate a statin was excluded from the study. In the real world, outside of clinical trials, somewhere between 25 percent and 40 percent of people put on statins stop taking them within two years. The most common side effect, muscle pain, occurs in about 10 percent to 20 percent of people taking statins, and muscle biopsies have shown muscle damage in such people, even when their muscle enzymes (checked to look for muscle injury) are not elevated. Women are more likely than men to suffer this side effect, and to develop diabetes when placed on statins. Other statin side effects include kidney injury, nerve damage, tendon rupture, problems with memory and concentration, and cataracts.
In reality, how much benefit can a healthy person expect from statins? Doctors Aspry and Eaton quote figures of 25 percent reduction in risk from moderate dose statin and an additional 15 percent reduction from high dose statin. But these are relative risk reductions.
To make the math simple, if 2 percent of people on placebo in a study have a cardiac event over five years, and 1 percent of those taking a statin have an event, there is a 50 percent relative risk reduction. But the absolute risk reduction is only 1 percent! You would have to treat 100 people for five years to prevent one event. Ninety-nine of those people would have no benefit from taking the statin but all would be exposed to potential side effects.
Based on studies involving tens of thousands of healthy people, for those who took a statin for five years, 98 percent saw no benefit, 0 percent were prevented from dying, 1.6 percent were prevented from having a heart attack, 0.4 percent were prevented from having a stroke, 1.5 percent were harmed by developing diabetes and 10 percent were harmed by muscle damage. These are the numbers physicians should be discussing with their healthy patients before prescribing statins.
There is a healthy alternative: the Mediterranean diet, a plant-based diet incorporating colorful fruits and vegetables, whole grains, sea food, olive oil as the main source of fat calories, and little meat or processed food. It has no side effects and lowers relative cardiovascular risk to the same degree as statins, both in people with and without vascular disease. That is my choice to reduce risk.
Barbara H. Roberts, M.D., is the director of the Women’s Cardiac Center at the Miriam Hospital and an associate clinical professor of medicine at the Alpert Medical School of Brown University. She is the author of “The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs.”