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    Wednesday, September 04, 2002

    Cholesterol Caution: Statins, a very popular class of cholesterol lowering drugs, have been linked to nerve damage:

    Researchers who studied 500,000 residents of Denmark -- about 9 percent of that country's population -- found that people who took statins were more likely to develop a form of nerve damage called polyneuropathy than those who never took the drugs. Polyneuropathy, also known as peripheral neuropathy, is characterized by weakness, tingling and pain in the hands and feet as well as difficulty walking.

    Taking statins for one year raised the risk of nerve damage by about 15 percent -- about one case for every 2,200 patients. For those who took statins for two or more years, the additional risk rose to 26 percent. The Danish study, published earlier this year in the journal Neurology, is not the first to implicate statins in the development of nerve problems, but as one of the largest statin studies to date it is regarded as significant.


    It’s really not all that impressive, though, as this synopsis makes clear. They looked at everyone who was diagnosed with nerve damage in the country without an obvious cause, and then found out how many had taken statins. Only 15 out of 166 people with idiopathic nerve damage had taken the drugs. The control group was made up of 4,150 people who had never had nerve damage. Of these, only 66 had ever taken a statin. There may be an association here between statins and nerve damage, but it isn’t a solid case based on these numbers.

    That’s not to say that statins should get a free pass. They shouldn’t. Their claim to fame is based on similar inflated numbers. They are among the greatest profit makers for the drug companies largely because physician groups like the American College of Cardiology and the American Heart Association have endorsed them as miracle drugs that are as safe as candy. In fact, here is their latest joint statement on the safety of statins:

    ...These agents reduce the risk of essentially every clinical manifestation of the atherosclerotic process; they are easy to administer, with good patient acceptance. There are very few drug to drug interactions

    Not true. There is a lengthy list of drug to drug interactions with statins.

    ..Statin therapy holds great promise for reducing the incidence of major coronary events, coronary procedures, and stroke in high-risk patients. At present, this potential has not been fully realized, because many patients at heightened risk are not being treated with these drugs. There is a well documented under-use of statins in clinical practice.

    Whether or not they are underused in clinical practice is a matter of debate. Many physicians aren’t as easily taken in by the claims for statins as the men and women who make up the scientific panels at the American College of Cardiology and the American Heart Association. Many of these panel members, not coincidentally, are dependent on the makers of statins for research grants. The American Heart Association, in fact, claims amongst its highest donors several drug companies that manufacture statins. (warning: pdf file). They’ve accepted claims that statins substantially reduce coronary artery disease based on comparisons of ratios rather than actual changes in disease incidence; which in all the studies, only amount to changes of 2 to 4 percentage points. See the results of the most lauded of the statin studies here, here, here, and here.

    Most recently, the American Heart Association and the American College of Cardiology have tried to expand the use of these drugs even further, by recommending that we screen and treat people as young as twenty for high cholesterol, possibly making statins the first drugs to be used everyday for a person's entire lifetime. What a market coup! They have plans to expand it even further. They're working on guidelines now that would recommend screening for markers of inflammation in the body that have a small correlation with heart disease risk. The buzz is that the inflammation can be successfully treated with statins, too.

    Not surprisingly, sales of statins are taking off:

    In fact, according to an article in the Wall Street Journal by Thom Burton, many insurers now grade doctors’ performances and dole out monetary bonuses and penalties based on measuring and “improving” patients’ cholesterol levels. And the fastest and easiest way for doctors to lower cholesterol is to prescribe a powerful statin like Pfizer’s Lipitor. As the new government guidelines are structured in such a way as to transform virtually every American into a candidate for cholesterol-lowering drugs, Pfizer’s profits are climbing. Income for the huge pharmaceutical company rose 38 percent in the last quarter of 2001 to $1.93 billion. Karen Katen, president of Pfizer’s human pharmaceuticals group, said Lipitor “still has enormous room to grow” because of “widespread under-diagnosis of high cholesterol.” (Wall Street Journal, 1/24/2002).

    The worst of it is that among all the statin boosterism not one study has been done to quantify the cost of long term statin therapy to society or to the individual. Shame on us.
     

    posted by Sydney on 9/04/2002 06:13:00 AM 0 comments

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