By David Brownstein, M.D.
The Associated Press ( AP ) reported on July 6, 2010 that the European Union approved a new form of cholesterol lowering medicine, a chewable tablet, for children aged 10 and higher with elevated levels of cholesterol and triglycerides.
The article further stated, "The approval includes children whose high blood fats are due to an inherited disease that causes extremely high cholesterol levels, familial hypercholesterolemia." In the U.S. (2002), Lipitor was approved for use in children with familial hypercholesterolemia.
What is familial hypercholesterolemia (FH)? It is a genetic disorder characterized by high cholesterol levels - usually high LDL (thought of as ‘bad') cholesterol levels. It affects well less than 1% of the population.
The media and many prominent cardiologists would have you believe that having a diagnosis of familial hypercholesterolemia markedly increases the risk of cardiovascular disease and proves the hypothesis that elevated cholesterol levels are responsible for cardiovascular disease.
However, the research about familial hypercholesterolemia actually disproves the hypothesis that elevated cholesterol levels are responsible for cardiovascular disease.
So, what does the research show? Research on familial hypercholesterolemic patients shows that they can develop atherosclerosis at a very young age. However, research has also shown that people with familial hypercholesterolemia live at least as long as people without the condition and fewer die from cancer as well as other diseases.
For those individuals who have familial hypercholesterolemia, there is no difference in cholesterol levels between those that suffer an early death from cardiovascular disease and those that live to an old age. Other researchers have shown that FH patients who live to an older age actually have higher LDL cholesterol levels. ( Ref: i, ii, iii )
You might think that lowering cholesterol levels in FH patients would lower their risk for developing heart disease. However, for those most seriously affected with FH, lowering cholesterol levels with statin or other drug therapies as well as surgery has little effect. ( Ref: iv )
So, do children with FH or high cholesterol levels need statin drugs? My opinion is that giving a child a statin drug for any condition is a recipe for disaster. A child's growing body needs and requires cholesterol. The nerve tissue requires adequate amounts of cholesterol to form the correct synapses. The brain will not develop normally without adequate cholesterol levels.
Yes, those with FH, produce abnormally large amounts of cholesterol. However, since the studies have not shown that lowering cholesterol levels improves longevity (in anyone, not just FH patients), I see no valid reason for statin use in FH cases. Also, with the child's nervous system and brain constantly developing, the use of statin drugs imposes the risk of serious adverse affects in children.
Why would Big Pharma member Pfizer (maker of Lipitor®) spend the money and test Lipitor® on a condition (FH) that has a very low incidence? Furthermore, why would Big Pharma spend the money to lobby the FDA and European Union for approval in treating an illness that does not affect a large number of children? For the answer to these questions, you need to follow the money. Lipitor is an older drug about to come off patent. In 2009, sales of Lipitor® topped 13 billion dollars worldwide. Once it comes off patent, the sales of Lipitor® will plummet as generics take its place.
In the AP article, it was reported that Pfizer plans to apply for a six-month extension of its patent after doing its studies of Lipitor® on younger patients. In the U.S. and EU, drug makers are allowed to apply for an additional six months of patent protection if they test their drug in children. With 13 billion dollars of sales/year, an additional six months of patent protection can bring in enormous amounts of money.
Have statins been shown to improve longevity in either FH or non FH patients? No.
Have they been shown to lower the risk of a fatal heart attack? No.
Do they lower the risk of a non fatal heart attack? The best that statins have been shown to do in anyone is a 1% reduction in non fatal heart attacks over two to three years of use.
The research on statins certainly does not warrant their widespread use.
The side effects from statins include muscle pain, memory loss and brain dysfunction, premature aging, liver dysfunction, muscle breakdown and weakness, lowered immunity, fatigue, and blood sugar dysregulation. In my opinion, statins should certainly not be given to children.
More information about statin drugs can be found in my book, Drugs That Don't Work and Natural Therapies That Do, 2nd Edition.
David Brownstein, M.D.
David Brownstein, M.D. is a family physician who utilizes the best of conventional and alternative therapies.
He is the Medical Director for the Center for Holistic Medicine in West Bloomfield, MI.
i. Arterioscler. Thrombosis. 11. 290-7. 1991
ii. Circulation. 92. 290-5. 1995
iii. Am. J. Cardiol. 87. 2001.
iv. Curr. Atherosclorosis Reports. VOl. 4. N. 1. January 2002
Dr. Brownstein has authored nine books:
Drugs that Don't Work and Natural Therapies That Do
The Miracle of Natural Hormones
Overcoming Thyroid Disorders
Iodine: Why You Need It, Why You Can't Live Without It
The Guide to Healthy Eating
Salt Your Way to Health
The Guide to a Gluten-Free Diet
The Guide to a Dairy-Free Diet