There has been no more profitable class of drugs than the cholesterol-lowering statins. Their success is based on a very simple premise: High cholesterol levels mean certain cardiovascular death. While there has always been questioning of the cholesterol story at the fringes of academic research (1), now the cries are rising within the highest reaches of the academic research community that something is just not right.
Since no one wants to die, you would think that measurement of mortality would be the primary clinical end-point for any clinical trial of a statin drug. There is no question that for people who have already had a heart attack, taking a statin prolongs their life by reducing all-cause mortality. But what about the people who have never had a heart attack but have high cholesterol levels? There the answer is much more open.
One recent article has studied all the published studies with some 65,000 patients who had high cholesterol but no evidence of heart disease to see the effect that statin drugs have on their mortality (2). The answer was virtually none. In fact, in all the statin trials published since 2005, there has been a striking lack of benefits in populations that simply had high cholesterol levels but no evidence of any cardiovascular disease (3). This is true except for one trial that was funded by a drug company that makes a new powerful, statin and run by the individual who has the patent for measuring C-reactive protein as a marker for cardiovascular risk (3).
Here was a new premise: People who had normal levels of cholesterol and no heart disease but high levels of C-reactive protein also need even more powerful statins. The fact that C-reactive protein is an unreliable marker in cardiovascular patients because it changes so quickly was conveniently ignored (4). Nonetheless a successful trial would generate more sales for the drug company and more testing of C-reactive protein for everyone going to see a physician.
So when a careful analysis of this “highly-successful” trial was published this year, it was found that there were no benefits in reducing cardiovascular mortality between the active and placebo groups (3). As the cholesterol story appears to have a growing number of flaws in it, I predict it will become more commonplace to have drug companies and medical researchers continue to use sleight-of-hand statistical dodges to make it appear their “wonder” drugs are actually doing wonderful things, like reducing death from heart disease in those who have no evidence of heart disease.
Maybe it’s time to return to a better working hypothesis of what really drives heart disease—inflammation and to use anti-inflammatory diets to prevent the occurrence of cardiovascular disease (5,6).
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