Statins: Deus Ex Machina Solution for Heart Disease? Or is it a Can of Worms for More Health Issues?

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I want to start this post off with a personal story. I recently had a family member have a knee replacement and I volunteered to run to the pharmacy and pick up their prescriptions for them. When I left the pharmacy with what I thought was the entire pharmacy (I picked up 18 different medications) I noticed there was a statin drug in there (Simvastatin to be more precise). When I dropped off the medication I asked why she was talking the statin and what her cholesterol numbers were and was shocked by the answer. She informed me that her total cholesterol was 90, her HDL was about 25, and that her doctor prescribed her a statin to keep her cholesterol levels low because she has a history of CHD and that it was standard of care.

When I left I called a primary care physician and ran the scenario by him and asked his opinion on the topic and his response was eye-opening. He told me that due the contemporary notion that cholesterol causes heart disease medical practitioners prescribe statins in this scenario for two reasons: 1) statins lower blood cholesterol, thus preventing CHD and are safe drugs, 2) that if a patient with a history of CHD is not given a statin and develops CHD the medical care provider may be sued for malpractice. This scenario terrifies me and highlights some of the huge issues we face in modern health care.

Statins

Statin drugs are highly controversial in the field of health and nutrition. They are currently touted as an effective medication for preventing and treating coronary heart disease (CHD) and are a multi-billion dollar industry for pharmaceutical companies with Lipitor, the most popular of the statin drugs, producing sales of over $14 billion in 2006. Statins proclaim to be a “Deus Ex Machina” for CHD by reducing cholesterol production by inhibiting the enzyme (HMG CoA Reductase) responsible for producing cholesterol in the liver

The proposed mechanism for the role of statin drugs in reducing and preventing cardiovascular disease is based on the paradigm that cholesterol is the cause of heart disease. This paradigm and the role cholesterol plays in heart disease has been shown to be incorrect and that cholesterol may not be the main culprit in heart disease. If you follow the work by Chris Masterjohn, Chris Kresser, and Robb Wolf you may be familiar with the inadequacies of the cholesterol and heart disease hypothesis. If their analysis of the role cholesterol plays in heart disease is correct, and I believe it is, then the lack of evidence for the efficacy of statin use in preventing CVD related mortality makes logical sense.

The purpose of this post is to highlight the lack efficacy of statin use in preventing heart disease and the dangers of statin use.

Do Statins Reduce Mortality Related to CVD?

A large body of peer-review research has been conducted on the efficacy of statin drugs in reducing CVD related mortality. I want to start the review with a trial that actually does show that statins reduce CVD related mortality, but it comes at a price. This study was a randomized controlled trial (RCT) in the prime target population for statin use, the at risk elderly individuals.

In this study the authors found that in an elderly, at risk population, Pravastatin did indeed reduce CVD mortality by roughly 6.5%; however, this reduction was offset by increased cancer diagnosis.

What about the effect on healthy, middle-aged individuals? In a study published in JAMA in 2004, the authors found that “for women without CVD, lipid lowering does not affect total or CHD mortality”. The same study found that in women with known CVD, the drugs showed a slight reduction in CVD related mortality but not a reduction in all cause mortality.

The use of statins in secondary prevention of CHD has also been researched. In an RCT published in the BMJ examining the effect of statin as a measure of secondary prevention use on all cause mortality, the authors found fewer deaths in the statin treatment group. This study however has some major flaws that confound their results, so major in fact that I can’t believe it was even published. Here are the limitations of their study pulled straight from the paper, “Our study has some limitations. Firstly, we assumed that if a prescription was filled then patients would comply with treatment, but we had no way of knowing whether patients actually took their treatment. Secondly, we were limited by the number of covariates on which we had data. Consequently we were not able to adjust for smoking, obesity, and exercise.” I don’t know about you but I wouldn’t even start a campfire with the paper I printed this study out on, it is that worthless.

I could continue to build an argument that statin’s are not an effective tool in reducing CHD related mortality in the general population. However, I would rather refer you to the sources mentioned earlier, Chris Masterjohn, Chris Kresser, and Robb Wolf, as they built their arguments quite eloquently and I want to move onto the “can of worms” I mentioned in the title.

Statin’s Can of Worms

If you have been a diligent reader of my blog or of any other paleo-centric blog in the past few years you no doubt know that cholesterol is an essential molecule for maintaining and sustaining life. It can even be argued that cholesterol is what separates mammals from plants and allows us to thrive as human beings.

Statin use and Myopathy

Myopathy is the medical term for muscle disease and unexplained sources of myopathy have been associated with statin use. In fact, a quick google scholar search for “statin induced myopathy” yields 9,470 scholarly articles. There is a vast amount of information on the topic but I want to hit on the key points.

A 2008 article in the British Journal of Medicine reviewed the symptoms and occurrence rates, and potential. The spectrum of statin induced myopathy includes myalgia, myositis, rhabdomyolysis and increase creatine kinase. The same author also noted that in prospective clinical trials up to 10-13% of participants develop myalgia (muscle pain). With the current use of statin drugs, these equates out to over 1.5 million cases of statin induced myalgia. It is mind-blowing to me that the pharmaceutical industry currently sells drugs that cause over 1.5 million people each year unneeded and undesirable pain.

Recent studies in animal models have proposed mechanisms for these side effects including necrosis of muscle fibers, reduction in mitochondrial volume and oxidative capacity, and muscle cell apoptosis.

When I look at studies such as these it causes me a great deal of concern. Our muscles are a key regulator in our metabolic processes and the deleterious effects of statin use on our muscles may lead to disregulation of muscle and whole body metabolism. A hypothesis which may partially explain the next issue, statin use and diabetes

Statin Use and Diabetes

It is no secret that our country is currently facing an obesity/diabetes epidemic. These two conditions often go hand-in hand and also are highly correlated with CHD. Statins are designed to theoretical reduce the risk of CHD, yet recently it has been shown that statin use increases the risk of developing diabetes.

In a meta-analysis published in the Lancet in 2010, the authors combined the results of 13 statin trials with over 91,000 participants and examined the incidence of diabetes.

This study is a great example of how “Big Pharma” can spin the data to suit there needs. The authors found that statin therapy was associated with a 9% increased risk for diabetes. This seems quite shocking especially when we refer back to the “golden child” study which showed a 6.5% decrease in CHD related mortality. Now I would conclude from these findings that statin therapy may have deleterious effects on metabolic control and ought to be studied closer, but the authors made the following conclusion, “Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.” Ok, so why would scientists and researchers make such a conclusion based upon the data presented? Well I looked into who the researchers are and who fills their pockets. I could present the entire list to you ( it is on the right hand side of the second to last page of the study) but here the key contributors are Pfizer, Merck, AstraZeneca, Bristol-Myers, and Sanofi-Aventis, all pharmaceutical companies either producing statin drugs or benefiting from their sales.

Statins and Cardiomyopathy

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If you know me at all I love to play the devil’s advocate and I can’t help myself here either. For a moment, lets pretend cholesterol does cause heart disease and that statin therapy does reduce CHD by reducing cholesterol. Well our heart is a muscle and as we have talked about earlier, this hypothetical benefit may be offset by necrosis and apoptosis of muscle tissue and impaired mitochondrial function potentially through deleterious effects on CoQ10. CoQ10 is an enzyme that functions as an antioxidant, aids in the formation ATP during oxidative phosphorylation, and maintains proper pH in lysosomes. Chris Masterjohn does a great job explaining Statins and CoQ10 here. We know that cardiac cells run more effectively and efficiently through oxidation and ketone metabolism than anaerobic glycolysis and impaired mitochondrial function may contribute to myocardial dysfunction. Therefore, I would argue there might be grounds to build an argument that statin therapy actually cause cardio myopathy. Is there evidence to prove this? As it turns out there is. In a paper published in 2005, fifty patients with possible adverse statin side effects (including myalgia) discontinued statin therapy due to the side effects and began CoQ10 supplementation. The authors found that the cessation of statin therapy and CoQ10 supplementation lead to stabilization or improvement of heart function. The concluded from their results that, “ statin-related side effects, including statin cardiomyopathy, are far more common than previously published and are reversible with the combination of statin discontinuation and supplemental CoQ10. We saw no adverse consequences from statin discontinuation.”

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Is Low Cholesterol a Good Thing?

One thing we know for sure about statins is this. They are indeed effective in reducing the endogenous production and synthesis of cholesterol and they can and do reduce your cholesterol numbers. However, is low cholesterol a good thing? The short answer to this question would be a resounding “no”, and a more in-depth explanation can be found in a previous article I wrote here.

Summary

I know this was a lot of reading and I thank you for staying the course. The widespread use of statin therapy, especially in populations where it has shown no efficacy and based upon the observed side effects is downright dangerous. Unfortunately, due to the state of modern medicine, the power of “Big Pharma”, the slow changes in paradigms and the over abundance of lawsuit happy lawyers, statins are likely here to stay.

I must make a disclaimer. I am not a physician, did not attend medical school, and cannot give you medical advice. I do however have to ability to critically analyze information and implore you to do the same. If your physician is prescribing you with a statin ask him or her to read the literature with you, have an open conversation, and decide what the cost-benefit analysis of taking the medication is.

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