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The Facts about Statins & Cholesterol

by Lisa Orwick, DC

So you don’t want to die of cardiovascular disease. That makes sense, because heart disease is the number one killer in the United States. The ads all tell you to solve your problem by taking the cholesterol lowering drugs (statins.) Is cholesterol really the enemy they make it out to be? How much do you really know about the real causes of cardiovascular disease? About statins? About cholesterol? About the studies - who they cover and what they say?

A little known fact about cholesterol is that its role in the human body is vital. Cholesterol is the most common organic compound in our brain. It is an essential constituent of the membrane surrounding every cell in our bodies:
 

  • Cholesterol enables the body to make CoQ10, L-carnitine, and vitamin D.CoQ10 is extremely important in the body’s ability to make energy at the cellular level. The heart depends on CoQ10 and is usually the first to feel an energy shortage. Cholesterol is also vital for nerve conduction throughout the body.

  • Cholesterol is a precursor for the class of hormones known as steroids. Steroids are a group of hormones that determine our sexuality, control our reproductive processes, and regulate blood sugar and mineral metabolism. All steroid production (testosterone, estrogen, e.g.) requires cholesterol. 

  • Cholesterol is the parent of a parasteroid hormone called aldosterone and cortisol. Cortisol is known as a glucocorticoid, a very powerful mineral that helps control blood sugar, glucose metabolism, and is very important for the immune system function. 

  • Cholesterol is where we get something called calsitrol. Calsitrol is very important for maintaining proper levels of calcium in our bodies. Without Calsitrol the calcium would pass right through our bodies without being utilized. Calcium in our teeth and bones would diminish quickly, causing dental decay and osteoporosis. Calcium also facilitates nerve transmission to the muscles; without it muscles would fail. Exaggerated knee reflexes are a symptom of low calcium levels. 

  • Cholesterol is important in the production of bioacids. Bioacids are secreted by the liver and stored in the gall bladder and are what allows your body to digest fats. 

  • Cholesterol is an antioxidant and anti-inflammatory. When the body needs to reduce an inflammatory response or needs more antioxidants it responds by creating more cholesterol as a protective mechanism. 

  • On November 9, 2001, cholesterol was identified by a drug company to be a synaptogenic factor (necessary for an effective nerve synapse.) The Pfizer group found that nerve cells must have an external source of cholesterol to form synaptic connections. They discovered that one of the functions of glial cells (supporting tissue of the brain and spinal cord) is to produce their own cholesterol for the specific purpose of providing nerve cells with this vital synaptic component. The nervous system is the basis of neurotransmission - connecting the brain with the rest of the body. 


There were initial studies that seem to indicate that high cholesterol was a cause for cardiovascular disease, but many of the studies have since been found to be flawed or too narrow. However, the pharmaceutical companies have found that lowering cholesterol is the one parameter that they can manipulate with drugs. The pharmaceutical industry sends 80,000 sales reps to doctor’s offices each year with new and profitable medications. Our television sets are flooded with advertisements for these medications, ‘Take one now!,’ ‘Ask your Doctor!’ However, according to an article published in JAMA (Journal of American Medical Association) previously unrecognized serious side effects are discovered in 51% of new medications after their approval for use. Twenty percent (20%) of these approved prescription medications ultimately require a black box warning indicating severe or lethal side effects. The original statin drugs are Lipitor, Levocore, Mevacor, Zocor, Pravachol, and Lescol. The new statin drugs Atorvastatin, Lovastatin, and Simvastatin are much more lipophilic in nature (meaning they have an affinity to combine with lipids, aka: fats) and are far more capable of crossing the blood-brain barrier and introducing the drug into the central nervous system to lower cholesterol. It is a very disturbing concept that 1 in 2,000 people will develop nerve injuries that can be severe and permanent. With 20 million people in America taking statin drugs, ten thousand people per year will develop nerve damage. Some of the other side effects from Statin drugs such as Lipitor, Levocore, Mevacor, Atorvastatin etc, are: chronic muscle pain and injury, liver and kidney injury, psychological changes, cognitive impairment, global amnesia, and increased cataract formation.

Cholesterol is the most important and abundant molecule of our brain. Its creation is a 24 step process. Statin medications cut off this process at the third step, interrupting the production of vital nutrients CoQ10, L-Carnitine and Vitamin D. We don’t know what else is being lost with this drug interference. Dr. Oz reported that people who have low levels of Vitamin D are twice as likely to have a cardiovascular event. CoQ10 is vital for nerve conduction and reduced CoQ10 may result in muscle cells breaking down, resulting in increased muscle pain. Dr. David Gaist found that people on statin drugs are 16 times more likely to develop polyneuropathies. These disorders are often symmetric and frequently affect the feet and hands, causing weakness, loss of sensation, pins-and-needle sensations or burning pain. Diabetics are very prone to peripheral neuropathy. Statin drugs increase the chances of developing peripheral neuropathy as well as predisposing patients to heart attacks. Bay Col, one of the first statin drugs introduced, was taken off the market suspected of causing Rhabdomyolysis (a condition where the muscle cells break down and release myoglobin, causing a secondary blockage of the kidney tubules). Since 1987, 81 people have died from statin related Rhabdomyolysis. This doesn’t even recognize the thousands who suffer from muscle pain connected with taking statin drugs.

Drug companies know that statin drugs deplete CoQ10, and how dangerous it is. Merck obtained a patent to combine CoQ10 with statins, but CoQ10 is very expensive to produce and no action was taken on the patent. In Canada, the Lipitor warning label has been strengthened to include not only the warning of CoQ10 depletion but also L-Carnitine deficiencies. CoQ10 is vital to the formation of elastin and collagen (essential components of tendons and ligaments.) Inflammation and rupture of tendons and ligaments have been frequently reported with those on statin drugs. This is important because people with tendon and ligament issues who are also on statin drugs will have a harder time healing if their body is depleted of these crucial compounds. 

Studies on high cholesterol and/or the effectiveness of the statins to control it are varied and ambiguous. A long term study by Jackson et al. found that long term use of statins produced a one percent greater risk of death over 10 years verses the placebo. For short term use over 16 weeks by the patients with angina problems, the use of Lipitor @ 80 mg did not significantly change the death rates or rates of heart attacks. Dr McCully said that most glaring deficiency of the current cholesterol/high fat hypothesis is the fact that the majority of the patients with coronary heart disease or other forms of arterial sclerotic disease have no evidence of elevated cholesterol or LDL levels. It was a 1990 study of 194 consecutive autopsies of mostly male veterans that showed only 8% of the cases with arterial sclerosis had cholesterol levels greater than 240. They found the average blood cholesterol level with the most severe disease was 186, below the accepted value of 200.

In “The Homocysteine Revolution,” Kilmer McCully, M.D. found homocysteine, a byproduct of metabolism, to be a better risk indicator of heart disease than high cholesterol. B6, B12, and folic acid recycle homocysteine into harmless amino acids. Patients with deficiencies in folic acid, B6 and B12 have higher levels of homocysteine and higher prevalence of arterial sclerosis.  Vitamins B6, B12 and folic acid can reduce homocysteine levels, but this information is not promoted mainly because it is not in the best financial interest of drug companies.

The Framingham Heart Study used 1,000 subjects and determined that people with higher blood homocysteine levels had a greater degree of narrowing in the carotid arteries to the brain. In February 1998 Harvard School of Public Health published the results of the nurses’ health study that was conducted over a 14 year period, involving 80,000 participants. The test concluded that the nurses with the lowest consumption of folic acid, B6 and B12 had the highest rates of cardiovascular disease and heart attacks. Other researchers are looking at how trans-fats, omega 6 to omega 3 ratios, and magnesium deficiencies are inherent in the thrombotic tendencies and at how antioxidant deficiencies are also possible contributing factors. 

In 1996, the National Canadian Nutrition Study of 5,000 people over the duration of 14 years showed those with the lowest level of folic acid in their blood were almost twice as likely to die from heart disease as those with the highest levels. Dr. James Wright, a professor at the University of British Columbia, was the director of a government-funded therapeutics initiative, whose purpose was to pore over the data on particular drugs and figure out how they work. In a report published in BusinessWeek, Dr. Wright reported that drugs can be lifesaving in patients who already have suffered a heart attack, reducing the chances of recurrence that could lead to an early death. However, he found no benefit in people over the age of 65, no matter how much their cholesterol declined and no benefit in women of any age. He did see a small reduction in the number of heart attacks where middle-aged men were taking statin in clinical trials; but even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalizations, in spite of big reductions in their bad cholesterol.

The latest study published in Archives of Internal Medicine titled “Statins and All-Cause Mortality in High-Risk Primary Prevention: A Meta-analysis of 11 Randomized Controlled Trials Involving 65,229 Participants” (June 29, 2010.) The analysis of data found that people who have had a cardiovascular event in the past do have less chance of a repeat event and lower mortality rates when they take statin drugs. However taking the statins lowers cholesterol but does not prevent death from a primary cardiovascular event. The assumption is that if it helps prevent death from cardiovascular disease in people that have already had a cardiovascular event, it will help prevent death from a cardiovascular disease in the first place. This analysis of the 11 studies shows that it is just not the case. In the end, patients taking statins lowered their cholesterol, but had the same chance of dying from a cardiovascular event as the placebo group. In other words, lowering cholesterol did not prevent death from cardiovascular disease.

In Pfizer's own Lipitor newspaper advertisement, the dramatic 36% figure has been asterisked. Reading the small type, it says in a large clinical study, 3% of patients taking the placebo (sugar pill) had a heart attack compared to 2% of patients taking Lipitor. Understanding the small type, let’s do some simple math. The numbers in that sentence mean that for every 100 people in the trial (which lasted 3 1/3 years), three people on placebos and two people on Lipitor had heart attacks. That means there was one fewer heart attack per 100 people. To spare one person a heart attack, 100 people had to take Lipitor for more than 3 1/3 years. The other 99 received no measurable benefit and were subjected to the numerous and well-documented negative side effects. 

In other words,  in this one very favorable study presented by Pfizer, the number needed to treat (NNT) is 100. The ideal NNT is 1, which means one person taking the drug equals one person being helped. The larger the NNT, the less efficient the drug is. (By comparison, 1.1 is the number needed to treat for an antibiotic drug. This means that when 11 people take an antibiotic, the antibiotic is effective in 10 out of 11 people.) Several recent scientific papers have found the actual NNT, of statin medications for low-risk patients is 250 (and above), even if they take it for five years or more. In essence, you are putting 250 people in a room; they are told they will have to pay $1000 a year for 5 years for a statin medication and only one of them would get the benefit of not dying of cardiovascular disease. In addition, many of them will get diarrhea, chronic muscle pain and injury, liver and kidney injury, psychological changes, cognitive impairment, global amnesia, and increased cataract formation. 249 of them will spend $5000 over 5 years ($1,245,000) and not get any benefit at all. 

Pharmaceutical companies receive millions in profit and the underinsured public pays for the rising cost of insurance premiums. As of the year 2006, statin drugs were a 27.8 billion dollar per year industry.
In a radio interview, Robert A. Rakowski, cited a study published in a Journal called Biofactors. The 22-month study was on statins and recorded the following results: 64% people suffered from muscle pain, 84% suffered from fatigue, and 58% had difficulty breathing, 10% experienced peripheral neuropathies, and 8% had memory loss. The study suggested that the reason was because the cholesterol lowering drugs block the synthesis of a very important molecule CoQ10, one of the body’s most important nutrients for the cellular production of energy. CoQ10 is a very important antioxidant for heart and brain. In the study, the patients were taken off the cholesterol lowering drugs and were put on CoQ10, with the result that muscle pain was reduced from 64% to 6%, fatigue went from 84% to 16%, difficulty breathing went from 58% to 12%, peripheral neuropathies from 10% to 2% and memory loss from 8% to 2%. There was not one single negative effect from stopping the statin drugs. 

Dr. Bob Rakowski, a chiropractor and clinical nutritionist, had these things so say: 

  • Cholesterol is used to make all the steroids like estrogen, progesterone, testosterone and cortisol. It is also part of every single cell’s membrane. 

  • There are studies that show that people with higher cholesterol levels over the age of 70 live longer. There are studies that show that people with the lowest cholesterol die at an earlier age, most commonly from cancer. 

  • There are now associations with extremely low cholesterol to cancer and diabetes. There are several trials that show an association between statin use and the increase Of both cancer and diabetes. 

  • Those responsible for lowering of the acceptable cholesterol guidelines range from 240 down to 200 were shown (8 out of 9) to have financial ties to pharmaceutical companies that received profit from statin drugs. The 200 level still stands.

  • Forty percent (40%) of all people who have a sudden cardiac event do nothave any of the top 4 risk factors (high blood pressure, smoking, obesity or high cholesterol). Many of the latest studies show inflammation is one of the top factors responsible to cardiovascular disease. There have been studies on people who smoke and drink in excess, but still have low cholesterol. Researchers think their bodies aren’t healthy enough to produce the cholesterol. The studies also showed that they died prematurely, but the thought is that it was due to their unhealthy life style. 

  • Very few people know that cholesterol is a natural antioxidant and ananti-inflammatory. When the body needs to reduce an inflammatory response or needs more antioxidants it responds by creating more cholesterol as a protective mechanism. Cholesterol doesn’t become sticky and start blocking arteries until it is oxidized, which is caused by free radicals. The top 12 ways to create free radicals: smoke, emotional stress, toxins, excess sugar levels in the system, uncontrolled inflammatory process, methylization, infections, food reactions, poor digestion, hormone imbalances, heavy metal toxicity, mitochondrial energy dysfunction. In summary, it’s not the cholesterol itself that causes the problem but rather the damage to the cholesterol. CoQ10 is the #1 antioxidant for the heart. Remember: statin drugs decrease your CoQ10.

  • High-sensitivity C-Reactive Protein (hsCRP) is a measurement of inflammation that is much more accurate at diagnosing cardiovascular risk than cholesterol is. The liver makes hsCRP. Dr. Rakowski points out that when people take statin drugs, their ability to make the hsCRP is inhibited. Therefore, this creates a false negative because although tests show reduced hsCRP levels, it’s simply because you are damaging the liver and thus its ability to make hsCRP. Doctors monitor liver enzymes for those on statin drugs, because elevated enzyme levels indicate that liver damage is occurring.


So the question is: Why does the body have such high cholesterol levels? Most people don’t realize that only 10% - 20% of the cholesterol in the body is from dietary intake. Cholesterol is primarily present in animal products. Often times when people want to lower their cholesterol they end up avoiding meat and increasing their complex carbohydrate intake. When complex carbohydrates are increased, insulin will spike, which raises your triglycerides, total cholesterol, and LDL (bad cholesterol). Unfortunately, it also lowers your HDL (good cholesterol), as do statin drugs. HDL, the high-density lipoprotein (or "good") cholesterol helps carry bad cholesterol away from the walls of the arteries.

Doctors often use statin drugs to lower patient’s cholesterol to excessively low values. How concerned should we be with low cholesterol? There are 163 peer reviewed journal articles that link low cholesterol levels with suicide. They show that a negative effect of low cholesterol is a decrease in neurotransmitters, specifically serotonin. Serotonin is your ‘feel good’ neurotransmitter that most anti-depressants are trying to elevate. Studies cited by Peter Langsjoen have shown that people with very low cholesterol have shown aggressive behavior, violence, depression and mood disturbances, drug addiction relapses, memory impairment, dementia, hemorrhagic stroke, suicide, and heart failure in the elderly. In reference to an article published in the Lancet, people with the lowest levels of cholesterol have higher rates of death, cancer and infection. So it appears that cholesterol is protective against cancer and infection. There have been several articles detailing that people over the age of 70 with higher cholesterol live longer.

As you can see cardiovascular disease is quite complex. Dr. Lisa Orwick and Anna Burchard (lifestyle educator) recommend a twelve-week therapeutic lifestyle modification program (First Line Therapy.) The program is designed to decrease the risk for chronic diseases, specifically cancer, diabetes and cardiovascular disease. The program addresses appropriate lipid levels and addresses systemic inflammation with exercise, a modified Mediterranean diet and specific nutraceuticals. These nutraceuticals are designed to support the body in its healing processes and have no negative side effects. For more information click on the Nutrition/FLT button.

Sources:
Dr. David Gaist, May 15, 2002, “Statin Drugs May Increase Risk Of Peripheral Neuropathy” from
materials provided by American Academy Of Neurology
Professor James Wright, U. British Columbia, Jan 17 2008,“Do Cholesterol Drugs Do Any Good?”
BusinessWeek,
Robert A Rakowski, DC, CCN, DACBN, DIBAK, radio interview on cholesterol 
Duane Graveline, Nov 1, 2006, “Lipitor Thief of Memory” 
Jackson, et al., 2001, “Statins for primary prevention: at what coronary risk is safety assured?” Br J
Clinical Pharmacol ;52:439-46).
Kilmer McCully-Feb 2 2000, “The Homocysteine Revolution Called a Near Miss.” 
Peter H. Langsjoen, et. al., 1997, Lancet
Some reading suggestions: 
Dr. Uffe Ravnskov, March, 2003, “The Cholesterol Myth” 
Jay Cohen, May 19, 2008, “Overdose: the Case Against Drug Companies” 
Walter C. Willet 2005 "Eat, Drink And Be Healthy – The Harvard Medical School Guide to Healthy
Living"


Some Interesting Websites:
Business week: Do Cholesterol Drugs Do Any Good?
YouTube: Cholesterol lowering drugs do not benefit those over 65 

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