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Senator Questions FDA on Statin Side Effects

Posted Feb 17 2010 7:00am

Since the early 70’s, it has been politically correct to recommend a low-fat, low-cholesterol diet.   These recommendations are so firmly embedded in the consciousness of Americans that criticizing low-fat diets brings strong and adverse opinions.

Along with the demonization of saturated fats came cholesterol-lowering medications (statins). These drugs have been called “the most successful medicines in history”—but not for their success in curbing heart disease. In that regard, these drugs have been a royal flop.

Their “success” is for the manufacturers, who saw a staggering $33 Billion dollars in sales worldwide last year.   Pfizer’s Lipitor alone earned $13.6 million. 

Senator Charles Grassley (R-Iowa), senior member of the United States Senate and Ranking Member of the Committee on Finance, has been relentlessly probing conflicts of interest in medicine, with the goal of transparency. 

While it may be known there are conflicting links between doctors and pharmaceutical companies, for the past quarter of a century it has been hidden from public view.

The case is being made that these hidden relationships taint the integrity of medical research, device development, health studies, drug recommendations and, inevitably, patient care.

Recently Senator Grassley focused his attention on the FDA and cholesterol medications, when his investigators grew alarmed by the number of people complaining of serious side effects and long-lasting pain after taking statin drugs.

It is stated that statin side effects diminish once discontinued, yet growing evidence suggests that pain can continue for years after.  The Senator’s investigators discovered that side effects are under-reported. In addition, those patients who do report their complaints of severe pain, cramps and other side effects are not taken seriously by their doctors or are ignored altogether.

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Statin Question To The FDA

Senator Grassley sent the FDA a letter with the following questions:

  • Has the agency sufficiently considered potential problems caused by cholesterol-lowering drugs?

  • Is the agency seeing a lot of adverse events? 

  • Are the problems being adequately spotted and reported? 

  • Why are side effects listed in other countries missing from US labels? 

  • Are there problems with these drugs that aren’t being addressed?”

An agency spokesperson, Karen Riley, confirmed the agency received the letter and said, “We will review it and respond to the senator.”

His concerns are reflected in a study where researchers found that statins activate a gene signal in muscles called Atrogin-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 that is common among users of these drugs.

How Did We Arrive Here?

The suggestion that cholesterol would cause atherosclerosis began almost 100 years ago with feeding a high cholesterol diet to rabbits.  Since rabbits are genetic and historic vegetarians, it isn’t surprising this diet caused lesions to form in the arteries.

This, combined with the fact that human atherosclerotic plaque contained cholesterol, led to the faulty theory that elevated cholesterol in humans would cause atherosclerosis. 

The connection of saturated fat to human heart disease was made famous by Ancel Keyes, a physiologist from the University of Minnesota, who published his famous “Seven Countries Study.”

His study was reported to show a connection between the consumption of saturated fat and coronary heart disease.  Ancel Keyes was very persuasive with a strong and forceful personality. He was known to attack those who opposed his theory. 

However, at the time, the data existed to study 22 countries. But some of these countries demonstrated no association to saturated fat and heart disease, while others showed an inverse association. Keyes selected only the seven countries that fit his preconceived idea of cholesterol and heart disease and ignored the others.

To date no one has even postulated a mechanism by which saturated fat causes heart disease, other than an association with elevated LDL cholesterol.  In other words, the evidence to support this theory is scant.

Saturated Fats

Although there are more than a dozen types of saturated fats, humans predominately consume three—stearic, palmitic and lauric acid.  These three fats make up 95% of the saturated fat in a slice of prime rib, a slice of bacon, a piece of chicken skin and nearly 70% in butter and whole milk.

It is well established that stearic acid has no affect on cholesterol levels; in fact, stearic acid is converted in the liver to oleic acid which is mono-saturated like olive oil.  Most scientists now consider stearic acid to be benign or potentially beneficial.  

Palmitic and lauric acid raise LDL-cholesterol levels, but they also raise HDL cholesterol levels, and may therefore also be beneficial.

We can safely say that if saturated fat is only bad because it raises LDL cholesterol levels and LDL cholesterol levels are not the cause of heart disease, then saturated fat is not the cause of heart disease.

The Evidence Mounts 

Americans faithfully followed the low-fat diet for about 40 years.  During that time, saturated fat consumption and the average blood cholesterol levels dropped, as was intended. However, heart disease rates continued to increase, year after year.   

Obesity also continued to climb steadily. Currently, 65% of the population is overweight or obese and diabetes has reached epidemic proportions.

Now there is mounting evidence that there’s no benefit and probably harm from low-fat diets.

Notable Health Studies

The Women’s Health Initiative (WHI) Atherosclerosis Risk in Communities studied 48,835 women with no benefit from a low-fat diet in terms of heart disease or breast cancer.

The NursesHealth Study has followed 90,000 females, once again demonstrating no reduction in heart disease or cancer from a low-fat diet.

Even the famous Framingham Study now admits there is no association between fat and heart disease.

The American Heart Journal (1/09)reported that of 137,000 people admitted to over 500 hospitals with evidence of heart attack, 75% of those admitted had LDL-cholesterol levels below the recommended level of 130; 50% had LDL-cholesterol levels below 100, and 17% had cholesterol levels below an incredibly aggressive target of 70.

The recent ENHANCE study was designed to prove that Vytorin (a combination of Crestor and Zetia) could slow the growth of plaque in carotid arteries supplying the brain more than Crestor alone.  Even though the combination drug, Vytorin, reduced LDL cholesterol 40% lower than Crestor by itself, there was no difference in the progression of atherosclerotic plaque.

The recent JUPITER Study (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) conducted by pharmaceutical giant, Astra-Zeneca, examined 17,000 people with normal LDL-cholesterol but elevated CRP (a marker for inflammation).  This group was treated with Crestor.

The study was widely reported as demonstrating that Crestor would reduce cardiac events in this study group. In the 1.9 years duration of the study, the actual event rate dropped from 1.8% in the placebo group to 0.9% in the treated group.

What this really means is out of 120 people treated over 1.9 years with Crestor, only one heart attack was avoided. Crestor costs about $3.50 per pill.  To prevent one heart attack, stroke or death the cost would be $166,000 (data from theheart.org) 

That the CRP fell in the treated group demonstrated that if statins have any beneficial affect, it is lowering inflammation—not lowering LDL cholesterol.  As a caveat, there are more effective and healthy ways to lower inflammation than statin medication.

What You Can Do Now

While the scientific evidence establishes that low-grade inflammation is the underlying mechanism of atherosclerosis, the mindset of the nation has been conditioned to believe that cholesterol is evil and is the cause of heart disease.   

That’s understandable, with statin commercials dominating nightly TV and physicians clinging to traditional cholesterol lowering recommendations.

You could wait for Senator Grassley’s investigations to conclude before making the decision it is time you rejected tired, worn-out and useless theories that are harming your health.  As a heart surgeon who spent 25 years in the practice of medicine, I can assure you he’s on to something.

A far better suggestion is to take control of your health by learning how the faulty theories of low-fat diets, unnaturally tampering with cholesterol levels and eliminating saturated fat have created epidemics of inflammation, heart disease, diabetes and obesity.

You have more power to make positive changes in your health and heart than I ever did as a cardiovascular surgeon.  Understanding how arterial inflammation causes heart disease is neither mysterious nor complicated. In fact, it is far easier to understand than you might think.

Follow the recommendations in my book, The Great Cholesterol Lie, and you’ll soon see that returning inflammation to healthy levels results in vast physical improvements and well-being you haven’t felt in years. 

How do I know?  If you’ve been following the typical American diet with the typical American lifestyle, it was not possible that you avoided unhealthy levels of inflammation and plaque in your arteries.

The good news is you can begin today, right now, by making a few simple yet powerful changes such as taking an adequate amount of Omega-3 to put out the fires of inflammation, adding essential nutrients known to be deficient in our typical American lifestyle and eliminating foods that are the inflammatory culprits.  

There are “facts” and there are theories—in The Great Cholesterol Lie, you’ll discover the facts that will help you form a new awareness and understanding that you are not likely to see in TV commercials where mass marketing prevails over medicine.    

Take control today and you’ll soon see your body is a marvelous self-healing organism very capable of repairing itself.

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