The Statin Scam Marches On
Monday, December 10, 2007
Byron J. Richards, Board Certified Clinical Nutritionist
Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media this month: “Statins Found to Turn On Gene that Causes Muscle Damage.” It’s now a fact of science; a new study shows that taking statins destroys your muscle to a greater or lesser degree. And let’s not forget that the heart is a muscle.
Place this study juxtaposed to another rather interesting recent finding: the more fit you are the longer you will live – and the two just don’t add up. How can you destroy muscle and be more fit? You can’t. Sure you can drug your cholesterol number lower, but will you be healthier, fit, and live longer?
In the new study researchers found that statins activate a gene signal in muscles called atrogen-1. When this gene activates it targets key muscle proteins for destruction. The activation of this gene drives the process of muscle atrophy and muscle wasting. It is induced in cardiac muscle in failing hearts. Why on earth would any person want this gene activated by a drug?
The researchers tested statin-taking humans who were complaining of severe muscle pain. Muscle biopsy found that the atrogen-1 gene was activated, compared to people with severe muscle pain not on statins and controls. They went on to show through various experiments that statins activate the gene. This is extremely bad news for any person taking a statin.
Right now doctors ignore the majority of muscle aches and pains caused by statins, and in their mind only consider the problem serious when it is debilitating (rhabdomyolysis), which apparently happens less than 1% of the time. However, at least 5% - 7% of statin users experience significant muscle problems. The number is greater than 10% if a person is taking the now commonly prescribed higher doses. And if a person is trying to be fit and exercise the number jumps to 25%. These numbers are clearly on the low end as it has now been shown that doctors are ignoring their patients, not reporting the side effects of statins to the FDA, and telling them the side effects they are experiencing are not from the drug!
This new science shows that as soon as the atrogen-1 gene is activated by statins it starts destroying muscle. This means that even mild aches or pains while taking a statin is a sign that muscle is being destroyed, an entirely new and sobering perspective on the side effects of statins. Statins directly work against being physically fit, as is evidenced by the difficulty statin users have exercising without troubling symptoms.
Cardiomyopathy (serious weakening of the heart muscle) is a known adverse and often not reported side effect of statin therapy, previously thought to be the result of a statin-induced coenzyme Q10 deficiency. It is likely that the combination of Q10 deficiency with atrogen-1 activation is behind this problem.
Statins – Perversion of Science for Profit
The statin industry is a 20-billion-a-year propaganda machine, producing more yearly revenues from one class of drug than all professional U.S. sports combined. Just like any hot-selling drug on the market, negative studies are discouraged to say the least. They are either thrown in the trash can when they don’t work out or critical researchers are often blackmailed, meaning if they publish something negative they will never again get research money from the industry. These well known tactics discourage basic research on drug-related toxicity problems.
When statistics are honestly looked at in the case of using statins for many years to prevent a first heart attack, for every life that is saved (1% over 10 years use) statins cause an equal number of adverse deaths due to accidents, infection, suicide, and cancer (1% over 10 years use). This means that as a general public health measure, which is now the lion’s share of current statin use, they are an ineffectual waste of money. It has now been proven that middle-age men would be better off taking an aspirin a day for a tiny fraction of the cost (of course there are many supplement options). Statin-taking for a number of years does not reduce mortality rate. None of these facts faze the statin industry, which keeps churning out positive spin and moving right along regardless of the damage being doing and the money wasted.
The fraud of statins inside one’s body centers on the regulation of an enzyme known as HMG CoA reductase. Statins work by reducing the function of this enzyme, the higher the dose the more the enzyme is reduced, and the less cholesterol is made. It is well known that individuals with naturally lower cholesterol (LDL at 130, total less than 200) in their 40s and 50s have fewer cardiovascular problems as they grow older. However, taking a statin to reduce cholesterol to these levels or even lower is not the same thing as natural healthy function.
In healthy individuals with lower cholesterol the HMG CoA reductase enzyme is active at a high level as part of health. It is part of a complex communication system within the body that regulates energy, immunity, fat metabolism, leptin, cellular thyroid hormone activity, liver-related synthesis, stress tolerance, adrenal function, sex hormone synthesis, and brain function. This system is core to survival! The high activity of this enzyme is a type of metabolic fitness, similar to the idea of muscle fitness. The enzyme is very active in a healthy state for a variety of important and vital needs.
Drugging this enzyme is similar to making a person get around in a wheelchair, whether they need one or not. If you put a person’s metabolism in a statin-induced straightjacket, then maybe Humpty Dumpty won’t fall off the wall so easily. That may be a useful concept for someone in brittle cardiovascular health, but it has little to do with the average person concerned about general cardiovascular well being and maintaining a healthy level of fitness and vitality.
Doctors don’t use statins to try and reduce HMG CoA activity a little bit, with the idea of approximating some type of healthy function of the enzyme (the lowest and least toxic dose possible to provide improvement). Doctors actually could care less what healthy function of the enzyme actually is. Rather, the new “gold standard of medical care” is to batter the enzyme into a state of submission so that cholesterol levels are abnormally low. Any apparent benefits of a statin, many of which are falsely touted, is accomplished by poisoning some aspect of health. How long can such a charade be allowed to continue on millions of unsuspecting Americans? Why won’t the FDA demand drug companies include a correct risk profile as part of the labeling? As normal, the FDA continues to sleep on duty.
Double the Dose – Rake in the Billions
In 2004 the government-funded National Cholesterol Education Program selected a panel of nine “experts” to review statin drug use and make recommendations as to guidelines doctors should follow to reduce cardiovascular disease. They recommended that individuals at high cardiovascular disease risk attain LDL levels < 100 mg/dL and individuals at very high cardiovascular risk attain LDL levels < 70 mg/dL (levels that are abnormal, levels which are seldom ever this low in healthy people with no cardiovascular disease). Their advice was published in the marketing journal of the American Heart Association, Circulation. This “scientific journal” failed to disclose that six of the nine authors had direct financial ties to the makers of statin drugs.
Today, in doctor’s offices around the country, these abnormal cholesterol levels are being pushed on anyone over the age of 40, requiring a double or triple dose of statins or combination with some other toxic drug (like fibrates) to achieve these completely unnatural and unhealthy levels of cholesterol. In hindsight we can see that these recommendations boosted yearly statin sales by seven billion dollars. A class-action lawsuit has already been filed against Pfizer for illegal Lipitor promotion. Many others are sure to follow as this fraud becomes better understood by those who are injured and those footing the bill.
Further highlighting this fraud is a study appearing in the October 3, 2006, issue of the Annals of Internal Medicine. Researchers reviewed all studies relating to cholesterol-lowering benefits by statin drugs, with a focus on the new abnormally low cholesterol levels promoted by the American Heart Association. Their conclusion, “current clinical evidence does not demonstrate that titrating lipid therapy to achieve proposed low LDL cholesterol levels is beneficial or safe.” That is a rather shocking conclusion coming more than two years after the fact. The finding did not faze the statin marketing machine or the prescribing habits of any physician.
Make Vitamin E a Scapegoat
During the time in 2004 that Big Pharma was plotting its statin bonanza it needed to fire cannonballs at its most widely recognized competition, Vitamin E and other antioxidants. No problem. First, in August 2004, the American Heart Association used its marketing magazine to print a bogus article contradicting hundreds of nutritional studies, stating that antioxidants A, C, and E are not effective for cardiovascular disease risk reduction. Then, in November of 2004, with trumpets blaring at their yearly AHA meeting, they make the brazenly fraudulent claim that vitamin E increases the risk of death by 6%!!!
Outside the marketing meeting masquerading as a scientific conference, the chairman, Dr. Raymond Gibbons of the Mayo Clinic in Rochester, Minnesota, was holding a dog and pony show press conference. “I spend all my time trying to tell patients why they should not take vitamin E. Too often in terms of the supplements there’s very scant science. In this area, we have the science. Vitamin E doesn’t work.” He implored his captive audience of reporters to help him convince patients to stop taking Vitamin E and take the “proven” drugs. The next day, all major media ran the story telling consumers vitamin E was dangerous. Program effective. Damage done.
Within weeks the American Heart Association had brainwashed doctors and the American public to actually think vitamin E was dangerous, clearing out the primary competition to statins for the prevention and treatment of cardiovascular disease. Doctors were telling all their patients to stop taking vitamin E. The anti-vitamin rhetoric spread like wild fire through doctor’s offices around the nation and continues to this day.
Within a week the bogus vitamin E information coming from the American Heart Association meeting was debunked. Physician and nutritional expert, Alan Gaby, pointed out all the flaws as well as the safe and effective track record of vitamin E. By April of 2005 the leading antioxidant scientists in the world had published a comprehensive review showing the safety of vitamin E up to doses of 1600 IU per day, again debunking the false vitamin E story and explaining the high degree of safety of antioxidant nutrients. The media was nowhere to be found; the public never heard vitamin E was truly safe and vital for immune function, prevention of cognitive decline, and a wonderful nutrient for cardiovascular support.
In July of 2005, the Journal of the American Medical Association published the results of an amazing vitamin E and heart disease study. After tracking 40,000 women for eight years it was proven that vitamin E lowered the risk of cardiovascular death by 24%! However, JAMA authors, going along with the vitamin E smear campaign, concluded that vitamin E was not worth recommending! Any drug with that kind of statistical evidence would be a billion dollar blockbuster. The media failed to look at the study and reported everywhere that vitamin E was not needed, denying women the true information about a wonderful cardiovascular support nutrient.
Likewise, an August 2007 randomized, double-blind, placebo-controlled cardiovascular study published in the Archives of Internal Medicine found that natural vitamin E reduced cardiovascular death or serious cardiovascular disease by a statistically significant 13%, the primary end point of the study. Natural vitamin E also showed improvement in secondary end points, including a 22% reduction in heart attacks, a 27% reduction in strokes (31% when combined with vitamin C), and a 9% reduction in cardiovascular death. Once again the study results were hidden deep in the paper, downplayed by the authors, and not correctly reported in the media. And in November the American Journal of Clinical Nutrition reported the results of another randomized, double-blind, placebo-controlled vitamin E study showing that vitamin E was completely safe at doses of 1200 IU per day in patients with existing cardiovascular disease. Once again the media was nowhere to be found.
It is hard to calculate how many elderly people have been injured and killed by the proclamation not to take vitamin E and to take statins in super-high doses. Vitamin E is absolutely vital for heart function and healthy immunity in older Americans. When a statin-taking senior dies the physician never notes the deterioration of health that often begins with taking a statin or increasing the statin dose. Rather, the physician simply blames the health of the patient for the death – isn’t that convenient. Thus, statin-induced deaths are hidden and grossly under-reported.
A New Statin Fraud Emerges
The statin golden pot at the end of the rainbow has recently been threatened due to the fact that several best-selling statin drugs have lost patent protection and are now open to generic competition for pennies on the dollar ((Lipitor sales are off 25%). Newer cholesterol drugs in the pipeline have turned out to be a total bust. In order to get insurers to keep coughing up unnecessary money Big Pharma had to be creative – and dishonest (no surprise there).
Merck and Schering-Plough have joined forces to market Zetia (which works in the digestive tract differently than a statin) and Vytorin (which is a combination of Zetia and a statin). By combining a statin in this way generic competition can be avoided. Either Zetia or Vytorin sell for $3 a day, compared to $0.25 for a generic statin. By adding Zetia to any other statin or by taking the combination pill cholesterol can be lowered an additional 15%. This has created a $5 billion dollar share of the statin market for these two drugs.
Is lowering cholesterol an extra 15% worth it? That is the billion dollar question. Forbes was the first to blow the lid on what is obviously a rip-off. The Wall Street Journal is also covering the story. Vytorin has never been proven to prevent heart attacks, strokes or deaths any better than a plain generic statin. In 2002 Merck/Schering Plow undertook a study to prove that the combination prevented plaque build up in the arteries better than a statin alone. The study was completed in April of 2006. The drug companies are sitting on the results, and now have announced they are changing the primary outcome of the study after it is done – a scientific farce.
It is obvious that the top executives in these companies know the results are not good. They can’t throw the data away as their marketing campaign was built on the expectation of a favorable outcome of these studies. Even doctors are complaining about the stalling tactic. The longer they can stall the longer they can collect their $5 billion in yearly sales, swindling Americans of hard earned money. This is, unfortunately, an example of typical drug company behavior. The FDA is of course snoozing on the job – they should be warning consumers of the dangers of lowering cholesterol excessively.
Take Health into Your Own Hands
The medical profession has lost almost all credibility. There is no short cut to being healthy. The majority of drugs are best used for a short duration, which is not in the best interest of Big Pharma profits. Some people in poor health need to be managed with drugs. Drugs as a tool for general health and prevention are a travesty. The statin industry is a scam gone wild. Space in this article has only allowed me to define a few of the primary statin side effects. There are many more that are seldom explained, including weakened immunity and cognitive decline. Statins are a slow and insidious poison wherein the side effects gradually get worse the longer a person takes them. This means that people often don’t realize their decline in health is from the statin, until someone points this issue out to them and they look at how their health in general has deteriorated since being on a statin. No, it’s not that the person is simply getting older – it’s the statin! You may read about all the statin side effects for free in my book, Fight for Your Health: Exposing the FDA’s Betrayal of America (chapters 19-21).
If we want a renaissance in cardiovascular fitness and quality of life in the over 50 crowd then most of the meds need to go in the trash and be replaced with consistent exercise programs, a fresh and organic diet, stress management programs, improved quality of sleep, and appropriate dietary supplements that support fitness and healthy cardiovascular function. Seniors need to have a rightful and respected place in our culture.
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