Article reminds us of the importance of focusing on drug effects on health (not cholesterol)

Back in November I wrote about a study which, like others that came before it, casts doubt about the benefits of cholesterol reduction. In this study, combining a stating with ezetimibe (which reduces cholesterol absorption from the gut) produced less favourable outcomes than a statin coupled with niacin (vitamin B3) in terms of arterial health. According to one commenter referring to this and other studies “”there is not a shred of evidence that it [ezetimibe] does anything good for blood vessels or heart disease.”

The repeated failure of ezetimibe to do anything apparently useful was picked up last week in a piece which appeared in the Journal of the American Medical Association [1]. One of the important points made by the piece is that ezetimibe was licensed by the FDA in the US on the basis of its cholesterol-lowering properties. The piece goes on to highlight the fact that this ‘benefit’ has not been proven to translate into real clinical benefit (say, in terms of reduced risk of heart attack or death). The questions asks why so many doctors are prepared to prescribe a drug that has not been proven to do anyone any good.

In response to this, one commenter attributes this at least in part to people’s inability to question their own actions. “Physicians say, ‘This is my practice, and I think I am doing the right thing,’” was his comment. Another commenter suggested “There is a problem in America, and that is clinical inertia,” he said. “When evidence comes out, physicians are slow to change their prescription patterns.”

Another reason for the enthusiasm doctors appear to have for ezetimibe concerns the effective marketing of this, essentially, unproven agent. Its success is based on its ability to reduce cholesterol, remember, not on any evidence that it saves peoples lives or prevent heart attacks.

The article quotes Peter Kim, president of Merck Research Laboratories (Merck makes and markets ezetimibe). He says “Given the broadly accepted, scientifically validated importance of lowering LDL and the millions of people in the United States alone who are not at their recommended treatment goals, Vytorin [a combination of the statin simvastatin and ezemetimibe] and Zetia [ezetimibe] remain effective options for physicians to treat their appropriate patients.”

Obviously, one would expect a representative of Merck to attempt to put our focus on cholesterol rather than the absence of evidence for clinical benefit. The thing is, though, even if cholesterol reduction is broadly beneficial, that does not mean that something that reduces cholesterol is automatically beneficial. As I’ve mentioned before, if a known poison such as arsenic or cyanide was shown to have cholesterol-reducing properties, that would not be a reason for swallowing that poison every day.

Also, is cholesterol-reduction really beneficial? Previously, I have reported on evidence which links lowered cholesterol levels with an increased risk of death, with particular links to an increased risk of cancer. And perhaps it’s important not to forget that ezetimibe itself has been linked with an increased risk of death due to cancer.

Make no mistake about it, the aggressive and effective marketing of ezetimibe should remind us of just how important it is to have drugs licensed not on the basis of their impact on supposed markers of health (e.g. cholesterol levels), but on actual health and risk of disease and death.

References:

1. Mitka M. Cholesterol Drug Lowers LDL-C Levels But Again Fails to Show Clinical Benefit. JAMA. 2010;303(3):211-212.

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5 Responses to Article reminds us of the importance of focusing on drug effects on health (not cholesterol)

  1. Kay 29 January 2010 at 5:30 pm #

    It must surely be difficult for a GP to refuse to prescribe a drug such a large percentage of the medical profession, and the media, is trumpeting for its life-saving potential.

    How would that GP feel if a patient whom he or she had not prescribed it for subsequently died of heart disease? Is it not a case of better safe (and not sued) than sorry?

  2. Faith Dolden 29 January 2010 at 7:48 pm #

    I was prescribed ezetimbe by my doctor because my cholesterol was high in spite of taking atorvastatin for quite some time. This was instead of Simvastatin which gave me pains in my muscles. After reading your report I stopped taking ezetimbe and told my doctor the reason why. He made no comment except to say that perhaps a level of 5 was okay for me. I continue to take atorvastatin and keep my diet as healthy as I can. It would seem that my body is inclined to make this ‘overload’ of cholesterol regardless. ~What else can I do ? Faith

  3. Gabriella 29 January 2010 at 11:43 pm #

    Hi Faith -
    why don’t you read about the benefits of high cholesterol and its importance in the body in this article:
    http://www.westonaprice.org/The-Benefits-of-High-Cholesterol.html

    And in related matters, why don’t you read about the benefits of traditional fats in your diet? For this, the link would be:
    http://www.westonaprice.org/The-Skinny-on-Fats.html

    I put myself on a low-carb, high protein and fat diet and my cholesterol has actually gone down as predicted. Plus, I feel better and I am losing a lot of extra pounds.
    Good luck! Gabriella (from Santa Barbara, CA.)

  4. Craig 30 January 2010 at 11:52 am #

    Hi John,
    It’s sad that cholesterol keeps getting the bad guy status from mainstream conventional medicine with so much quality research out there contradicting the link between it and heart disease. Uffe Ravnskov’s ‘Cholesterol Myths’ and A. Colpo’s ‘The Great Cholesterol Con’ are fantastic books in my opinion highlighting this point.
    Could cholesterol (amongst other important roles) be playing the fireman in many cases and putting out fires (inflammation) and trying to shoot them down with statins (which may look good on the lab report) does nothing to address the underlying causes. If that was the case is the C- reactive protein test more valuable for testing inflammation and preventing heart disease? Actually nice to see even the American Heart foundation mentions this http://www.americanheart.org/presenter.jhtml?identifier=4648

  5. Margaret Wilde 30 January 2010 at 11:20 pm #

    Reducing one’s intake of salt and salty food is a safe, effective, drug-free way to lower the risk of heart disease and a host of other degenerative conditions. And incidentally, it lowers cholesterol too!

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