Statin effect dubious for prevention

Excerpts courtesy of the Los Angeles Times

24 million Americans take statins — marketed under such commercial names as Pravachol, Mevacor, Lipitor, Zocor and Crestor — make tens of billions a year for their manufacturers. In 2009, U.S. patients filled 201.4 million prescriptions for statins, double the number in 2001.

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins — called "primary prevention" — has driven the growth in the market for statins over the last decade. Today, a majority of people who use statins are doing so for primary prevention of heart attacks and strokes. It is this use of statins that has come under recent attack.

"There's a conspiracy of false hope," says Harvard Medical School's Dr. John Abramson, who has cowritten several critiques of statins' rise, 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 relationship between cholesterol-lowering and heart disease is still not perfectly understood. Archives of Internal Medicine recently argued whether statins prevent, safely and at a reasonable cost, the development of cardiovascular disease in people who are still healthy but are considered to be at high risk of a heart attack or stroke. In the first of three studies, 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 and concluded the widely hailed trial was "flawed" and raises "troubling questions concerning the role of commercial sponsors." "Tens of billions of dollars of revenue for the sponsor over the patent life of the drug were at stake in the JUPITER trial, as well as potentially millions of dollars in royalties for the principal investigator," wrote Dr. Lee Green of the University of Michigan Medical School in an editorial accompanying the trio of studies.

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