Dangers of Statin Drugs

June 21, 2011

By Sally Fallon and Mary G. Enig, PhD

Hypercholesterolemia is the health issue of the 21st century. It is actually an invented disease, a “problem” that emerged when health professionals learned how to measure cholesterol levels in the blood. High cholesterol exhibits no outward signs—unlike other conditions of the blood, such as diabetes or anemia, diseases that manifest telltale symptoms like thirst or weakness—hypercholesterolemia requires the services of a physician to detect its presence. Many people who feel perfectly healthy suffer from high cholesterol—in fact, feeling good is actually a symptom of high cholesterol!

Doctors who treat this new disease must first convince their patients that they are sick and need to take one or more expensive drugs for the rest of their lives, drugs that require regular checkups and blood tests. But such doctors do not work in a vacuum—their efforts to convert healthy people into patients are bolstered by the full weight of the US government, the media and the medical establishment, agencies that have worked in concert to disseminate the cholesterol dogma and convince the population that high cholesterol is the forerunner of heart disease and possibly other diseases as well.

Who suffers from hypercholesterolemia? Peruse the medical literature of 25 or 30 years ago and you’ll get the following answer: any middle-aged man whose cholesterol is over 240 with other risk factors, such as smoking or overweight. After the Cholesterol Consensus Conference in 1984, the parameters changed; anyone (male or female) with cholesterol over 200 could receive the dreaded diagnosis and a prescription for pills. Recently that number has been moved down to 180. If you have had a heart attack, you get to take cholesterol-lowering medicines even if your cholesterol is already very low—after all, you have committed the sin of having a heart attack so your cholesterol must therefore be too high. The penance is a lifetime of cholesterol-lowering medications along with a boring lowfat diet. But why wait until you have a heart attack? Since we all labor under the stigma of original sin, we are all candidates for treatment. Current edicts stipulate cholesterol testing and treatment for young adults and even children. The drugs that doctors use to treat the new disease are called statins—sold under a variety of names including Lipitor (atorvastatin), Zocor (simvastatin), Mevacor (lovastatin) and Pravachol (pravastatin).

How Statins Work
The process begins with acetyl-CoA, a two-carbon molecule sometimes referred to as the “building block of life.” Three acetyl-CoA molecules combine to form six-carbon hydroxymethyl glutaric acid (HMG). The step from HMG to mevalonate requires an enzyme, HMG-CoA reductase. Statin drugs work by inhibiting this enzyme—hence the formal name of HMG-CoA reductase inhibitors. Herein lies the potential for numerous side effects, because statin drugs inhibit not just the production of cholesterol, but a whole family of intermediary substances, many if not all of which have important biochemical functions in their own right. The possible consequences of taking statins in strong doses or for a lengthy period of time—depression of mental acuity, anemia, acidosis, frequent fevers and cataracts.

Cholesterol is one of three end products in the mevalonate chain. The two others are ubiquinone and dilochol. Ubiquinone or Co-Enzyme Q10 is a critical cellular nutrient biosynthesized in the mitochondria. It plays a role in ATP production in the cells and functions as an electron carrier to cytochrome oxidase, our main respiratory enzyme. The heart requires high levels of Co-Q10. A form of Co-Q10 called ubiquinone is found in all cell membranes where it plays a role in maintaining membrane integrity so critical to nerve conduction and muscle integrity. Co-Q10 is also vital to the formation of elastin and collagen. Side effects of Co-Q10 deficiency include muscle wasting leading to weakness and severe back pain, heart failure (the heart is a muscle!), neuropathy and inflammation of the tendons and ligaments, often leading to rupture. Dolichols also play a role of immense importance. In the cells they direct various proteins manufactured in response to DNA directives to their proper targets, ensuring that the cells respond correctly to genetically programmed instruction. Thus statin drugs can lead to unpredictable chaos on the cellular level, much like a computer virus that wipes out certain pathways or files.

Cholesterol
Of course, statins inhibit the production of cholesterol—they do this very well. Nowhere is the failing of our medical system more evident than in the wholesale acceptance of cholesterol reduction as a way to prevent disease—have all these doctors forgotten what they learned in biochemistry 101 about the many roles of cholesterol in the human biochemistry? Every cell membrane in our body contains cholesterol because cholesterol is what makes our cells waterproof—without cholesterol we could not have a different biochemistry on the inside and the outside of the cell. When cholesterol levels are not adequate, the cell membrane becomes leaky or porous, a situation the body interprets as an emergency, releasing a flood of corticoid hormones that work by sequestering cholesterol from one part of the body and transporting it to areas where it is lacking. Cholesterol is the body’s repair substance: scar tissue contains high levels of cholesterol, including scar tissue in the arteries.There are many other important roles of cholesterol, too many to detail in this paper.

Enter the Statins
Statin drugs entered the market with great promise. They replaced a class of pharmaceuticals that lowered cholesterol by preventing its absorption from the gut. These drugs often had immediate and unpleasant side effects, including nausea, indigestion and constipation, and in the typical patient they lowered cholesterol levels only slightly. Patient compliance was low: the benefit did not seem worth the side effects and the potential for use very limited. By contrast, statin drugs had no immediate side effects: they did not cause nausea or indigestion and they were consistently effective, often lowering cholesterol levels by 50 points or more. During the last 20 years, the industry has mounted an incredible promotional campaign—enlisting scientists, advertising agencies, the media and the medical profession in a blitz that turned the statins into one of the bestselling pharmaceuticals of all time. Sixteen million Americans now take Lipitor, the most popular statin, and drug company officials claim that 36 million Americans are candidates for statin drug therapy. What bedevils the industry is growing reports of side effects that manifest many months after the commencement of therapy; the November 2003 issue of Smart Money magazine reports on a 1999 study at St. Thomas’ Hospital in London (apparently unpublished), which found that 36 percent of patients on Lipitor’s highest dose reported side effects; even at the lowest dose, 10 percent reported side effects.

Muscle Pain and Weakness
The most common side effect is muscle pain and weakness, a condition called rhabdomyolysis, most likely due to the depletion of Co-Q10, a nutrient that supports muscle function. Dr. Beatrice Golomb of San Diego, California is currently conducting a series of studies on statin side effects. The industry insists that only 2-3 percent of patients get muscle aches and cramps but in one study, Golomb found that 98 percent of patients taking Lipitor and one-third of the patients taking Mevachor (a lower-dose statin) suffered from muscle problems. A message board devoted to Lipitor at forum.ditonline.com contains more than 800 posts, many detailing severe side effects. The Lipitor board at contains more than 2,600 posts. Active people are much more likely to develop problems from statin use than those who are sedentary. In a study carried out in Austria, only six out of 22 athletes with familial hypercholesterolemia were able to endure statin treatment. The others discontinued treatment because of muscle pain.

Neuropathy
Polyneuropathy, also known as peripheral neuropathy, is characterized by weakness, tingling and pain in the hands and feet as well as difficulty walking. 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 polyneuropathy. 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.

According to the research of Dr. Golomb, nerve problems are a common side effect from statin use; patients who use statins for two or more years are at a four to 14-fold increased risk of developing idiopathic polyneuropathy compared to controls.11 She reports that in many cases, patients told her they had complained to their doctors about neurological problems, only to be assured that their symptoms could not be related to cholesterol-lowering medications. The damage is often irreversible. People who take large doses for a long time may be left with permanent nerve damage, even after they stop taking the drug.

Heart Failure
Cardiologist Peter Langsjoen studied 20 patients with completely normal heart function. After six months on a low dose of 20 mg of Lipitor a day, two-thirds of the patients had abnormalities in the heart’s filling phase, when the muscle fills with blood. According to Langsjoen, this malfunction is due to Co-Q10 depletion. Without Co-Q10, the cell’s mitochondria are inhibited from producing energy, leading to muscle pain and weakness. The heart is especially susceptible because it uses so much energy. Co-Q10 depletion becomes more and more of a problem as the pharmaceutical industry encourages doctors to lower cholesterol levels in their patients by greater and greater amounts. Fifteen animal studies in six different animal species have documented statin-induced Co-Q10 depletion leading to decreased ATP production, increased injury from heart failure, skeletal muscle injury and increased mortality. Of the nine controlled trials on statin-induced Co-Q10 depletion in humans, eight showed significant Co-Q10 depletion leading to decline in left ventricular function and biochemical imbalances. Yet virtually all patients with heart failure are put on statin drugs, even if their cholesterol is already low. Of interest is a recent study indicating that patients with chronic heart failure benefit from having high levels of cholesterol rather than low. Researchers in Hull, UK followed 114 heart failure patients for at least 12 months. Survival was 78 percent at 12 months and 56 percent at 36 months. They found that for every point of decrease in serum cholesterol, there was a 36 percent increase in the risk of death within 3 years., Cognitive Impairment
An article in Pharmacotherapy, December 2003, reports two cases of cognitive impairment associated with Lipitor and Zocor. Both patients suffered progressive cognitive decline that reversed completely within a month after discontinuation of the statins. A study conducted at the University of Pittsburgh showed that patients treated with statins for six months compared poorly with patients on a placebo in solving complex mazes, psychomotor skills and memory tests.

Cancer
In every study with rodents to date, statins have caused cancer. Why have we not seen such a dramatic correlation in human studies? Because cancer takes a long time to develop and most of the statin trials do not go on longer than two or three years. Still, in one trial, the CARE trial, breast cancer rates of those taking a statin went up 1500 percent. In the Heart Protection Study, non-melanoma skin cancer occurred in 243 patients treated with simvastatin compared with 202 cases in the control group. Manufacturers of statin drugs have recognized the fact that statins depress the immune system, an effect that can lead to cancer and infectious disease, recommending statin use for inflammatory arthritis and as an immune suppressor for transplant patients.

Pancreatic Rot
The medical literature contains several reports of pancreatitis in patients taking statins. One paper describes the case of a 49-year-old woman who was admitted to the hospital with diarrhea and septic shock one month after beginning treatment with lovastatin. She died after prolonged hospitalization; the cause of death was necrotizing pancreatitis. Her doctors noted that the patient had no evidence of common risk factors for acute pancreatitis, such as biliary tract disease or alcohol use. “Prescribers of statins (particularly simvastatin and lovastatin) should take into account the possibility of acute pancreatitis in patients who develop abdominal pain within the first weeks of treatment with these drugs,” they warned.

Depression
Numerous studies have linked low cholesterol with depression. One of the most recent found that women with low cholesterol are twice as likely to suffer from depression and anxiety. Researchers from Duke University Medical Center carried out personality trait measurements on 121 young women aged 18 to 27. They found that 39 percent of the women with low cholesterol levels scored high on personality traits that signalled proneness to depression, compared to 19 percent of women with normal or high levels of cholesterol. In addition, one in three of the women with low cholesterol levels scored high on anxiety indicators, compared to 21 percent with normal levels. Yet the author of the study, Dr. Edward Suarez, cautioned women with low cholesterol against eating “foods such as cream cakes” to raise cholesterol, warning that these types of food “can cause heart disease.” In previous studies on men, Dr. Suarez found that men who lower their cholesterol levels with medication have increased rates of suicide and violent death, leading the researchers to theorize “that low cholesterol levels were causing mood disturbances.” How many elderly statin-takers eke through their golden years feeling miserable and depressed, when they should be enjoying their grandchildren and looking back with pride on their accomplishments? But that is the new dogma—you may have a long life as long as it is experienced as a vale of tears.

Honolulu Hearth Program (2001)
This report, part of an ongoing study, looked at cholesterol lowering in the elderly. Researchers compared changes in cholesterol concentrations over 20 years with all-cause mortality. To quote: “Our data accords with previous findings of increased mortality in elderly people with low serum cholesterol, and show that long-term persistence of low cholesterol concentration actually increases risk of death. Thus, the earlier that patients start to have lower cholesterol concentrations, the greater the risk of death. . . The most striking findings were related to changes in cholesterol between examination three (1971-74) and examination four (1991-93). There are few studies that have cholesterol concentrations from the same patients at both middle age and old age. Although our results lend support to previous findings that low serum cholesterol imparts a poor outlook when compared with higher concentrations of cholesterol in elderly people, our data also suggest that those individuals with a low serum cholesterol maintained over a 20-year period will have the worst outlook for all-cause mortality [emphasis ours].”

Dietary Trials
Doctors and other health professionals claim there is ample proof that animal fats cause heart disease while they confidently advise us to adopt a lowfat diet; actually the literature contains only two studies involving humans that compared the outcome (not markers like cholesterol levels) of a diet high in animal fat with a diet based on vegetable oils, and both showed that animal fats are protective. The Anti-Coronary Club project, launched in 1957 and published in 1966 in the Journal of the American Medical Association, compared two groups of New York businessmen, aged 40 to 59 years. One group followed the so-called “Prudent Diet” consisting of corn oil and margarine instead of butter, cold breakfast cereals instead of eggs and chicken and fish instead of beef; a control group ate eggs for breakfast and meat three times per day. The final report noted that the Prudent Dieters had average serum cholesterol of 220 mg/l, compared to 250 mg/l in the eggs-and-meat group. But there were eight deaths from heart disease among Prudent Dieter group, and none among those who ate meat three times a day. In a study published in the British Medical Journal, 1965, patients who had already had a heart attack were divided into three groups: one group got polyunsaturated corn oil, the second got monounsaturated olive oil and the third group was told to eat animal fat. After two years, the corn oil group had 30 percent lower cholesterol, but only 52 percent of them were still alive. The olive oil groups fared little better—only 57 percent were alive after two years. But of the group that ate mostly animal fat, 75 percent were still alive after two years.

What About Aspirin?
The other drug recommended for prevention of heart attacks and strokes is aspirin. Estimates suggest that 20 million persons are taking aspirin daily for prevention of vascular accidents. Yet at least four studies have shown no benefit. A study using Bufferin (aspirin and magnesium) showed no reduction in fatal heart attacks and no improvement in survival rate but a 40 percent decrease in the number of nonfatal heart attacks. Commentators reported these results as showing the benefit of aspirin, ignoring the fact that magnesium is of proven benefit in heart disease. Aspirin inhibits the enzyme Delta-6 Desaturase, needed for the production of Gamma-Linoleic Acid (GLA) and important anti-inflammatory prostaglandins. This fact explains many of aspirin’s side effects, including gastrointestinal bleeding and increased risk of macular degeneration and cataract formation. Other side effects include increased risk of pancreatic cancer, acid reflux, asthma attacks, kidney damage, liver problems, ulcers, anemia, hearing loss, allergic reactions, vomiting, diarrhea, dizziness and even hallucinations (James Howenstine, NewsWithViews.com, April 21, 2004)., Read the Fine Print
The picture in a recent ad for Lipitor implies that cholesterol-lowering is for everyone, even slim young women. However, in the fine print we learn that Lipitor “has not been shown to prevent heart disease or heart attacks”! If the makers of Lipitor need to provide this disclaimer, after millions of dollars invested in studies, why should anyone risk side effects by taking their drug?

About the Authors
Mary G. Enig, PhD is the author of Know Your Fats: The Complete Primer for Understanding the Nutrition of Fats, Oils, and Cholesterol, Bethesda Press, May 2000.

Sally Fallon is the author of Nourishing Traditions: The Cookbook that Challenges Politically Correct Nutrition and the Diet Dictocrats, and Eat Fat, Lose Fat (both with Mary G. Enig, PhD), as well as of numerous articles on the subject of diet and health. She is President of the Weston A. Price Foundation and founder of A Campaign for Real Milk. She is the mother of four healthy children raised on whole foods including butter, cream, eggs and meat.

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