About 24 million Americans take statin drugs — including Pravachol, Mevacor, Lipitor, Zocor and Crestor — largely to stave off heart attacks and strokes.
But in recent months the drugs have come under tough scrutiny.
Statins were initially approved by the Food and Drug Administration for preventing repeat heart attacks and strokes in patients with high cholesterol. Used for that "secondary prevention" purpose, the drugs drive down the risk of another heart attack or stroke by lowering levels of LDL (or "bad") cholesterol.
Then physicians came to believe statins could also reduce the risk of a first heart attack in those with factors such as high LDL cholesterol or diabetes. Today, most people who use statins do so for such "primary prevention'' of heart attacks and strokes, a use that has become controversial.
"There's a conspiracy of false hope," says Harvard Medical School's Dr. John Abramson, who has co-written several critiques of the rise in statin use, including one published in June in the Archives of Internal Medicine. "The public wants an easy way to prevent heart disease, doctors want to reduce their patients' risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits."
The FDA assesses drugs' safety and effectiveness for specific use; but its judgments are based on preliminary data, most of it generated by a drug company seeking approval for its product.
Sometimes, by the time medical research and debate suggest a drug may not be all it's been cracked up to be, it's already become a bestseller. Statins, say some who study the relationship between medicine and the drug industry, seem to fit that pattern.
Statins appear to drive down the risk of heart attack or stroke by lowering the levels of fatty deposits circulating in the bloodstream. Research suggests that the drugs dampen inflammatory processes that can prompt deposits of plaque to break away from blood vessel walls and cause sudden blockages of arteries leading to the heart or brain.
And yet, the relationship between cholesterol-lowering and heart disease is not perfectly understood, and the precise role of inflammation in heart disease is also uncertain.
Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease.
The issue in the latest round of debate is whether statins prevent, safely and at a reasonable cost, cardiovascular disease in people considered to be at high risk of a first heart attack or stroke.
In the first of three studies published recently in the Archives of Internal Medicine, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins' use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study.
Statins still have ardent admirers, including cardiologist Steven Nissen of the Cleveland Clinic, who notes that even if statins do not reduce heart attack deaths, lives are improved by pushing a heart attack further into the future.
Harvard's Abramson, author of Overdosed America, said the best way to drive down the risk is not pills, but healthy diet, exercise, no smoking and moderate drinking.