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Two related events marked this week’s trip to visit my parents in Boca Raton.  My father proudly showed me his plummeting cholesterol and LDL cholesterol (termed “Lousy” cholesterol by his doctor to distinguish it from HDL “Happy” cholesterol).  And, my mother showed me the stock market drop that Schering Plough had taken that morning.  The two events were linked by Vytorin, the Schering Plough drug to lower cholesterol.

Vytorin is a combination of a statin drug (Zocor) and another drug (Zetia, actually made by Merck) that blocks absorption of cholesterol.  The ENHANCE study to study effectiveness of Vytorin was complete two years ago but the drug company dragged its feet in publishing for so long that a Congressional committee sent letters telling them to hurry it up.   Now we know why they delayed so long.  In the words of the lead researcher of the study (who had no relationship to the drug company), Vytorin showed “no result – zilch. In no subgroup, in no segment, was there any added benefit” for reducing plaque.  

Now let’s put this in perspective.  Statins made $18 billion dollars for their owners last year.  Vytorin and Zetia made $5 billion of this, despite having no proof that they worked.  THAT’S RIGHT…..THERE’S NEVER BEEN ANY PROOF THAT THEY WORK!  So much for FDA oversight.  According to TIME magazine, “the Food and Drug Administration would only say that it is ‘evaluating the available data related to the ENHANCE study’  (but) it should give the FDA good reason to evaluate how it approves future medications in this class.”

This comes on the heels of other bad news for the cholesterol-lowering mega-industry.  Research continues to accumulate that suggests that lowering LDL too much increases the risk of cancer, most recently in the American Journal of Cardiology 2007.  Although this did not look at statins per se, just levels of LDL, the authors (from Tufts University School of Medicine, where I have my clinical teaching appointment) concluded that “the risk of cancer is significantly associated with lower achieved LDL levels.  These findings suggest that …..the cardiovascular benefits of lower achieved levels of LDL-C may in part be offset by an increased risk of cancer.”

And let’s not forget the article in the January 2008 Wall Street Journal quoted in the New York Times as, “Do Statins Make You Stupid?” chronicling some of the evidence that there are cognitive side effects to statin drugs, particularly in women.

I’ve long been frustrated by the concentration on cholesterol (read Beyond Cholesterol) , which is basically a marker  for something, not a “good” or “bad” agent.  Now, the chickens are coming home to roost in this $18 billion dollar a year industry.

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One Response to “Vytorin and the Cholesterol Myth”

  1. on 03 Apr 2008 at 1:45 pm Frank Lee

    Hi,

    I agree with you that the FDA has been sleeping all these years. Or maybe they purposely close a blind eye to what is happening for reasons only known to themselves. Well done… keep it coming.

    leefrank
    http://cholesterol-digest.com

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