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Risks of Statin Drugs
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Dangers of Statin Drugs

A visit to any of the numerous health-oriented forums on the internet will quickly reveal hundreds of posts from dissatisfied statin users, describing an alarming array of side-effects: the most common being extreme fatigue, nausea, gastrointestinal problems, and muscle weakness and pain. Complaints about doctors' inability to link their recent health problems with statin use are frequent. In many instances, users report that they put two-and-two together themselves, stopped taking the drugs, and experienced significant or even complete remission of their symptoms. Frequent side effects are no doubt a major reason why up to 75% of people taking statins discontinue their use.

Of course, defenders of statins are quick to point out the low incidence of adverse effects in controlled, randomized clinical trials as proof of their alleged safety. If you look at these studies closely however you will find that when recruiting for statin clinical trials, researchers carefully screen for, and exclude, a wide range of individuals including women of childbearing age, those with a history of drug or alcohol abuse, poor mental function, heart failure, arrhythmia, and other cardiac conditions, liver and kidney disorders, cancer, "other serious diseases", and "hypersensitivity" to statins. Thus, the disparity between the widespread "real-world" prevalence of side effects from statin use and the low prevalence of side effects in clinical trials is hardly surprising. These trials exclude groups that comprise a significant proportion of the real world population, and can hardly be taken as a realistic barometer for the expected incidence of side effects in the general population.

And even with these strict exclusion criteria, there is evidence to show that the clinical experience with statins has been far from trouble-free. Data for the largest statin trial, the Heart Protection Study (HPS), suggest that the daily 40mg dose of simvastatin used was nowhere near as well tolerated as the authors would have us believe. A substantial number of patients did not enter the trial after a six week run-in before randomization; of the 63,603 potential trial participants who entered the original screening, only 32,145 proceeded to the run-in phase. Of these, 11,609 patients - over one third - dropped out before the official start of the trial.

Regardless of what Statin manufacturing companies would have us believe, the dangers from statin use are very real, as illustrated by the tragic death of Mrs. Elnoisa Calabio. Mrs. Calabio's story was presented at an FDA public hearing in May 2000:

"On October 7, 1999, at the age of 48, registered nurse, wife and mother, Elnoisa Calabio, succumbed to the end stages of irreversible dermatomyositis and interstitial pulmonary fibrosis directly caused by her use of a prescribed cholesterol-lowering medication, simvastatin (Zocor). Mrs. Calabio had no substantial risk factors for heart disease. Her blood pressure was controlled. Her cholesterol was slightly high, but not considered dangerous. Tragically, in her last days she knew that the cholesterol lowering drug her doctor had recommended to extend her life was in fact the cause of her fatal illness."

Sadly, Mrs Calabio's family is hardly alone in grieving the needless, statin-induced loss of a loved one. In August 2001, pharmaceutical giant Bayer was forced to withdraw Baycol (cerivastatin) from the market, after at least fifty-two deaths had been linked to the drug. Baycol was causing rhabdomyolysis, a condition characterized by severe muscle damage. This rare disorder occurs when a large number of skeletal muscle cells die, subsequently releasing massive amounts of muscle protein into the bloodstream. This muscle protein saturates the kidneys, effectively overwhelming their filtration capacities. Indeed, kidney failure was reportedly a major cause of death amongst the Baycol victims. Baycol is not unique in its ability to damage muscle - all the statins have been shown to produce muscle disorders in susceptible patients, and muscle pain is one of the most common reasons for patients being taken off statin drugs.(33) Researchers recently reported that some patients may suffer muscle deterioration caused by statins while still maintaining normal levels of creatine kinase, the most commonly used indicator of muscle damage.

Statin Drugs Can Cause Liver Damage

Statin drugs can cause abnormalities in liver function, occasionally causing mild hepatitis. In fact people with liver problems can not take Statin drugs at all even if they have very high LDL levels. Between one to three percent of people who start taking statins will have a mild to severe elevation in their liver enzymes. Thus, for about one in 5,000 patients, liver enzymes need to be monitored periodically to make sure the liver still functions reasonably.

Most physicians do blood tests when they start treating people with drugs like Lipitor. They are looking for elevated liver enzymes released into the blood. These enzyme levels are always present, but increase if there is damage to liver cells. All of the statins can cause an increase in these markers in the blood, and cause damage to the liver (hepatotoxicity). It appears that the likelihood of this happening is related to the dose of statins used. The higher the dose, the more likely it is that we will see increases in these markers. Increases in these markers. have been observed in 2-5 percent of patients taking statin drugs. Usually, the increase is reversed after the drug is stopped with no permanent liver damage. But If the drug is not stopped, there can be permanent liver damage.

Because statins have been linked to liver problems and muscle weakness. Many researchers have concluded that patients at low risk of heart disease should very carefully weight the benefits of using statins against the potential risks.

Statin Drugs Can Cause Nerve Damage

Shortly after statin drugs reached the global market, a Danish physician noticed reports of nerve damage in 14 patients. In 1999, he and his colleagues reported on seven of those cases, then wondered how commonly the side effect, called polyneuropathy, occurs. For this study, the researchers probed medical records of all 460,000 residents of a Danish county. They excluded patients with diabetes, which can cause nerve damage, and they accounted for the effects of any other medicines with neurological side effects.

The new study, reported in May in the journal Neurology but largely overlooked by heart experts, comes as drug manufacturers are working on next-generation cholesterol treatments — and as more baby boomers are urged to take the medications to lower their risk of heart attacks and strokes.

Study co-author David Gaist of the University of Southern Denmark says the findings ought to alert doctors to the possibility of nerve damage among patients on statins but should not discourage their use.

Other experts agree. Sidney Smith, chief science officer for the American Heart Association, called Gaist's study interesting, but pointed out that studies of the drugs' effectiveness in 50,000 people have not shown nerve damage as a significant finding. "Nevertheless, physicians should be aware of symptoms that might be related," he says.

Statin Drugs Can Cause Muscle Damage

According to Dr. Paul S. Phillips, a cardiologist at Scripps Mercy Hospital in San Diego, California, satin drugs are not only very expensive but have many side effects and are potentially very dangerous. Phillips has studied patients in his practice and has concluded that all statins have the potential to cause muscle damage (myopathy), which can lead to a fatal condition called rhabdomyolysis, in which the muscle completely breaks down. Bayer's statin drug Baycol was taken off the US market in August 2001, after the Food and Drug Administration (FDA) received at least 52 reports that people taking Baycol had died of rhabdomyolysis. Another 50 have since died, Phillips said.

He said many of his patients complain of severe muscle aches and fatigue while taking statins, even though they show no signs of muscle damage when their blood is tested for a key enzyme called creatine kinase. High levels indicate trouble. The American Heart Association ( news - web sites) and the American College of Cardiology have recommended that patients be taken off statins if their creatine kinase levels are 10 times normal.

Phillips decided to further study his patients with normal creatine kinase levels. He took samples of their muscle tissue while they were taking statins and also during an 8-week period when they were taken off the drugs. In a paper in the October 1st issue of the Annals of Internal Medicine, he reported that of the first four people studied, all had muscle tissue abnormalities that are rarely seen. These four patients also were very weak in stair-stepping and hip adductor strength tests. When the patients went off statins, they felt better, they were stronger and their tissue samples looked normal again, Phillips said. He is testing more patients and gathering more data, but said he thinks that the currently recommended muscle enzyme test may not detect muscle damage in some people who take statins.

He has started a Web site, www.impostertrial.com, to report updates of his findings, and to seek input from statin-takers who are having muscle aches.

Statin drugs deplete essential CoQ10 reserves in the body

Coenzyme Q10 -- also called ubiquinone, which means "occurring everywhere" -- plays an important role in the manufacture of ATP, the fuel that runs cellular processes. In addition to this fundamental role in energy production, CoQ10 acts as a potent antioxidant. Though it is present in every cell in your body, it is especially concentrated in the very active cells of your heart. Not surprisingly, CoQ10 is extremely important for cardiovascular health, with high levels being found in healthy heart tissue.

Statins have been shown to deplete the body of Coenzyme Q10. Statins block enzyme pathways involved in the production of cholesterol, thereby lowering cholesterol levels. But the same enzymes that are involved in the production of cholesterol are also required for the production of coenzyme Q10; not surprisingly, lower cholesterol levels in statin users are accompanied by reduced levels of CoQ10.

Depriving the heart of CoQ10 is like removing a spark plug from your engine -- it just won't work. Low levels of CoQ10 are implicated in virtually all cardiovascular diseases, including angina, hypertension, cardiomyopathy and congestive heart failure.

Ironically, while statins are taken to reduce the risk of atherosclerotic heart disease, their CoQ10-robbing effects have been linked to an increased risk of congestive heart failure. Figures from the National Center for Health Statistics show that since the early nineties - when statin drugs began hitting pharmacy shelves - the incidence of congestive heart failure has risen sharply.(37) CHF, in fact, is the fastest growing cardiovascular disorder in the United States. Sadly, there is no cure for CHF short of a heart transplant. Peter H. Langsjoen, MD, a foremost authority on the use of coenzyme Q10 in the treatment of heart disease, has little doubt as to the culprit behind this sharp rise in CHF:

"In my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure secondary to statin usage, "statin cardiomyopathy". Over the past five years, statins have become more potent, are being prescribed in higher doses, and are being used with reckless abandon in the elderly and in patients with "normal" cholesterol levels. We are in the midst of a CHF epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes."

While CoQ10 is not only critically important for healthy cardiovascular function; the brain is also highly vulnerable to CoQ10 deficiencies. When healthy young men were given either statin drugs or a placebo, those taking lovastatin displayed significant deterioration in cognitive function after only three weeks of treatment.(37) Brian Vonk, M.D., of The Optimal Wellness Center, reported recently that, in his own experience and that of his colleagues, " statins cause depression or loss of motivation in the majority of patients, probably due to alteration of cholesterol metabolism in the brain. As a result, many of these patients are also on [antidepressant] drugs (e.g. Zoloft, Paxil, Prozac)."

Since the introduction of Statin drugs in 1987, Merck has known that statins deplete CoQ10 reserves, and knew that this could contribute to heart disease. In 1990, Merck sought and received a patent for Mevacor and other statin drugs formulated with up to 1,000 mg of coenzyme Q10 to prevent or alleviate cardiomyopathy, a serious condition that can cause congestive heart failure. Merck however, has not brought these combination products to market, nor have they educated physicians on the importance of supplementing CoQ10 to offset the dangers of these drugs to the heart. Because they hold the patent, other drug companies are prevented from coming out with a statin/CoQ10 product.

Statins and Cancer

In 1996 the Journal of the American Medical Association published an extensive review of the research studying the link between cholesterol-lowering drugs and cancer. The authors, Dr Thomas Newman and Dr. Stephen Hulley, stated: "All members of the two most popular classes of lipid-lowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animal exposure close to those prescribed to humans." In light of their findings, the authors recommended that: "lipid-lowering drug treatment, especially with the fibrates and statins, should be avoided except in patients at high short-term risk of coronary heart disease."

Newman and Hulley's recommendation has been all but ignored. Statins are being recommended and prescribed, not just to people at high short-term risk, but to perfectly healthy people who show no clinical manifestations of CHD whatsoever, except for the non-disease of hypercholesterolemia. Even children with "elevated" cholesterol levels are being urged to commence statin therapy

Drug companies and health authorities repeatedly assure us that statins are wonderful low-risk drugs that are well tolerated in most people. They claim that clinical trials have shown no increase in cancer incidence with statin use, but the longest of these studies ran for only 6 years (excepting the EXCEL trial, which showed an increase in total mortality after 1 year of lovastatin use, and for which no subsequent mortality data has ever been released(44)). Cancer is a chronic disease that may take decades to manifest itself as a life-threatening illness - can we really conclude from trials lasting five to six years that statins are safe for lifetime use? Even heavy smokers are highly unlikely to develop cancer within six years of taking their first puff; most continue for decades before they come to realize the true value of those little warnings adorning cigarette packets.

Because rodent studies routinely use far higher dosages of drugs than those prescribed to humans, some have questioned the relevance of Newman and Hulley's findings. In many studies, rodents have been shown to eliminate drugs much faster than humans, necessitating higher dosages to maintain constant blood levels of the drug. The authors noted, however, that when the drug exposure was considered in terms of blood levels, carcinogenicity occurred at levels close to those seen in humans. In the same journal in which this review appeared, a commentary critical of Hulley and Newman claimed that higher dosages used in rodents placed inordinate stress on their gastrointestinal tracts, and that most of the cancers seen in rodent studies were malignancies of the gastrointestinal tract and liver.(45) Given that gastrointestinal distress and liver toxicity are among the most frequently reported side effects in patients prescribed statins, this proffered explanation provides little reassurance.

Cancer Incidence In Human Statin Trials: A Closer Look.

The claim that statin trials have not shown any increase in cancer is disputed by the recent PROSPER trial, which found a 25% increase in newly diagnosed cancers among elderly individuals treated with pravastatin. While there were 20 less deaths from CHD and stroke in the treatment group, 24 more deaths from cancer were observed, and, in an ominous confirmation of animal findings, one of the highest increases was observed for gastrointestinal cancers.(46) The PROSPER authors dismissed these findings by referring to a pooled analysis they performed of eight statin trials that lasted three or more years, which showed no statistically significant difference in cancer incidence between the placebo and statin groups (6.9% versus 7.1%, respectively). However, most of these trials involved younger subjects. Because cancer risk increases with age, such a comparison bears little relevance to the PROSPER results. Due to their heightened risk, elderly subjects may act as a far more sensitive barometer to any cancer-promoting capacity possessed by statins.

Furthermore, as researcher Uffe Ravnskov, M.D., PhD., recently pointed out, the PROSPER researchers' analysis did not include skin cancer.(47) Considering the relatively short-term nature of statin trials, it is the incidence of such an easily detectable, superficial cancer that would provide the strongest clue as to the future cancer-causing potential of statins. Only two of the statin trials have reported skin cancer incidence; the 4S and HPS simvastatin trials. Increases in skin cancer were noted in both.

In the CARE trial, breast cancer, another readily detectable malignancy, developed in 12 women from the treatment group but in only one of the control individuals - a highly significant difference.(50) Breast cancer was also the malignancy for which the greatest increase was noted in the PROSPER trial. The possibility that statins will lead to future increases in cancer incidence cannot be flippantly dismissed.

To maintain their lipid-lowering effects, statins must be administered on a life-long basis. The reports of carcinogenicity from rodent studies and increases in superficial cancers noted in human trials warrant extreme caution. Given the complete lack of data on the effects of decades of statin administration, users can consider themselves part of a mass experiment in progress, the outcome of which is largely unknown.

Warnings for statin use to be limited to high-risk patients - where dramatically shortened life expectancies may override any concerns about long-term side-effects -have been completely overshadowed by the relentless promotional efforts of drug companies and enthusiastic endorsements from health authorities who are besides themselves at finally having clinical data that, on the surface, appears to support the lipid hypothesis.

Are we witnessing the unfolding of another officially-endorsed health disaster? Only time will tell. For those who do not want to find out the hard way, there are numerous non-drug measures that can help alleviate the risk of CHD. Randomized trials involving increases in fish/fish oil and/or fruit and vegetable consumption have produced risk reductions in mortality similar, and in some instances superior, to those seen in statin trials;(51-57) these safe, natural food items, as well as exercise, stress reduction, sound sleep, and a low glycemic load diet (i.e.., a low-to-moderate carbohydrate diet comprised of unrefined low glycemic foods), would be a far more judicious preventive alternative for those with no clinical signs of CHD.

Statin drugs cost a bundle and are dangerous.

They can cause liver, muscle, nerve damage and possibly cancer. If you're taking a statin drug (Zocor, Provacol, etc.), don't wait for your doctor to warn you of the substantial risks. Consider this fact: in the last 15 years (roughly the time that statins have been on the market), the incidence of congestive heart failure has tripled.

Click here for more info about Statin Drug Fraud

Click here for more info about Statin Drug Fraud

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