Dr. Mercola May 25 2002 1,361 views
The Food and Drug Administration (FDA) recently approved the first statin drug for use by children. While it may improve treatment of high blood cholesterol for some, it's also raising concern about inappropriate use of a powerful drug in kids.
The American Academy of Pediatrics (AAP) worries that the FDA's February approval of Merck's Mevacor (lovastatin) -- for children with a disorder that gives them very high blood cholesterol -- could fuel more statin use when there is still little long-term safety and efficacy data in children, said John Moore, a pediatric cardiologist at Philadelphia's M.C. Hahnemann Medical Center and chairman of the AAP's cardiology section.
There's also no consensus on how best to treat high cholesterol in youngsters, he said. The academy is expected to write new guidelines in late July.
The most recent National Cholesterol Education Program guidelines say drug therapy should be considered in adults when LDL (or "bad") cholesterol rises above 190, or above 160 when there are two or more risk factors for cardiovascular disease.
The same rules are usually followed in children, said Stephen Daniels, a pediatric cardiologist at the Cincinnati Children's Hospital Medical Center. There are no good figures on how many children have dangerous LDL levels, but the American Heart Association estimates that 10 percent of children aged 12 to 19 have high total cholesterol levels -- above 200.
Daniels predicted most pediatricians will be circumspect in prescribing Mevacor for children. "My guess is that there's not going to be an explosion in usage," he said. But others, like Moore, are less certain.
Mevacor was approved specifically for children aged 10 to 17 who have heterozygous familial hypercholesterolemia (HFH), an inherited condition that affects one in 500 Americans and puts them at very high risk for early heart disease and death.
But "off-label" use of statins for uses beyond those for which they are specifically approved is common. Many pediatric cardiologists use statins already to lower cholesterol in children, and it's possible that the approval of Mevacor for children will open the door to wider pediatric use for children with milder cholesterol problems.
In Merck's two studies of boys and girls with HFH, Mevacor cut cholesterol by 25 to 30 percent -- "on par with what we see in adults," said David Orloff, director of FDA's division of metabolic and endocrine drugs. But because the trials were short-term -- boys were studied for one year, girls for six months -- it is not known if Mevacor will slow the progression of heart disease in children or have unforeseen side effects.
Pete Kwiterovich, director of the University Lipid Clinic at Johns Hopkins University Medical Center and lead investigator in both trials, said the drug showed no evidence of two common statin effects -- liver and muscle damage.
Mevacor also did not appear to affect growth or sexual development during the period of study -- both particular concerns, since cholesterol plays a key role in growth and sex hormone synthesis.
Mevacor for children is the same formulation as the adult product but in a lower dose -- up to 40 milligrams a day, half that used in adults. Since the drug lost its patent protection last year, cheaper generics have become available. But the approval for use in children permits Merck to market the brand-name drug for that use, something the other statins, including the generics, may not do.
Washington Post, May 7, 2002; Page HE03
I never cease to be amazed at how much these drug companies can get away with.
They were able to get Mevacor approved for a relatively uncommon disease, familial hypercholsterolemia, of which only 1 in 500 people have.
However, as the article indicates, many physicians will start to use this drug for kids with cholesterol levels above 200.
This is nearly a guarantee to cause major disruptions in the health of children.
It is the rare person whose cholesterol does not radically respond to the eating plan. That is the basic first step. The next step is exercise. There are some people who don't respond to this regimen, but in my entire clinical career I can count them the number of patients I have seen on two hands that have failed to respond to this approach.
The normal cholesterol is probably around 200. Second of all total cholesterol is not the issue. The HDL/cholesterol ratio is a far more significant predictor of heart disease than total cholesterol.
Additionally, as the links below show, lowering cholesterol is not without risk and may cause a variety of complications in adults, let alone children who are far more susceptible with their immature endocrine systems.
Statin drugs are non-specific inhibitors of many liver enzymes and they will also reduce coenzyme Q-10 (CoQ10) which is profoundly important
CoQ10 helps convert food into energy at a very basic, cellular level and it is an antioxidant. CoQ10 is one in a series of ubiquinones, naturally occurring compounds produced in nearly every cell of the body, and was discovered as recently as 1957.
The primary function of CoQ10 (coenzyme Q10) is as a catalyst for metabolism - the complex chain of chemical reactions during which food is broken down into packets of energy that the body can use.
Acting in conjunction with enzymes, the compound speeds up the vital metabolic process, providing the energy that the cells need to digest food, heal wounds, maintain healthy muscles, and perform countless other bodily functions.
Because of the nutrient's essential role in energy production, it's not surprising that it is found in every cell in the body. It is especially abundant in the energy-intensive cells of the heart, helping this organ beat more than 100,000 times each day. In addition, coenzyme Q10 acts as an antioxidant, much like vitamins C and E, helping to neutralize the cell-damaging molecules known as free radicals.
So the drug companies continue to push guidelines so that more and more people will be recommended to take drugs which can cause serious nutritional deficiencies and don't solve the problem.
It's been just about one year since the drug companies were able to convince the federal government to change the cholesterol recommendations.
Prior to the new recommendations 13 million Americans "qualified" to be placed on these drugs. With these new recommendations 36 million Americans now qualify -- nearly triple the amount.
After all, that is the answer, isn't it? If people can't lower their cholesterol by following the low-fat nonsense then they need to take these drugs to prevent them from falling prey to the number one killer in the US, heart disease.
Hogwash. Nothing could be further from the truth.
If you have been receiving the newsletter for some time you will be familiar with my position on this issue. If not, I would encourage you to study the links below.
The big issue here is that these potent medications will be over the counter in the near future with a massive PR campaign to encourage people to swallow these potentially dangerous drugs.
The amazing thing about these new recommendations is that they completely ignore the previously published evidence that are quite clear in documenting that the actual cholesterol level itself is not the most important risk factor. It is actually the ratio between the level of total cholesterol and HDL.
The ideal HDL/cholesterol ratio should be higher than 25% and generally speaking the higher the better.
The ideal triglyceride/cholesterol ratio should be below 2.0.
If you did not know any better and just listened to the "experts" you would think cholesterol is an evil substance and that most of us would benefit from lowering our cholesterol as low as possible.
Not so. Cholesterol is a vitally important substance that is responsible for building our cell membranes and many of our hormones. If the level drops to low we are actually at increased risk for depression.
There are likely to be some people who benefit from them, but it is probably far less than 5% of the people who currently take them. These are individuals with total cholesterol above 350 who have inherited liver processing problems.
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