Tuesday, October 8, 2013
Statin and cholesterol update
In summing up more than 500 articles around cholesterol and the statin drugs used to treat cholesterol all I can conclude is that it is The Great Cholesterol Deception. To sum it up, however, the medical industry fudges the figures to fool the doctors that cholesterol is Public Enemy Number One. In fact, cholesterol is one of the most important bio-chemicals in the body and not a single life has ever been saved by lowering cholesterol. Many people suffer serious side effects as a result of taking statin drugs like Lipitor®, Zocor®, Crestor®, Pravachor and others.
Cholesterol is a normal part of our biochemistry and high levels—above six or seven—may be a symptom of an underlying health condition. But it is not the health condition itself. Elevated cholesterol predicts less than 35% of cardiovascular disease. In fact, most heart attack and stroke events occur in individuals without elevated cholesterol, at least half of all cardiac arrests occur in people with normal cholesterol levels and 20% occur in people without any traditional risk factors. But now the drug industry wants to lower the normal level of cholesterol even further so that almost everyone will have “high cholesterol.” At worst cholesterol is simply a messenger telling us there is stress on the liver, and it is not the killer it is made out to be. Cholesterol is a part of our immune, nervous and endocrine system and if high is only doing its job to protect us.
A significantly better predictor of the risk of heart attack or stroke is the concentration of Omega 3 oils in the blood: the higher the concentrations, the lower the risk 1,2,3,4,5,6,7,8, which predict up to 90% of CVD compared to 35% prediction from cholesterol readings. But there is no money to be made in prescribing Omega 3 oils. Omega 3 oils also reduce triglycerides and other risk factors for CVD, as well as reducing the risk of many other forms of chronic illness, from Alzheimer’s to arthritis and cancer. This is due to the anti-inflammatory effect of fish oils. Imagine if the specialists prescribed a few fish oils to patients. No one would require a specialist.
Millions of people are prescribed cholesterol-lowering drugs, statins like Pravachol®, Zocor® and Lipitor® each year, with no measurable benefit. Despite the media hype from poor and lazy journalism at best these drugs lower the actual risk of heart attack by around 0.3 percent and at the same time have side effects in 15% to 40% of people given statins 9,10,11,12 and serious side effects in as many as five percent of the population of users. And the studies of the side effects have only been short term. Most doctors will simply tell you that statins are safe and hand you a prescription. However if your GP reads the fine print there are two and a half pages of side effects. In some cases up to 65% of people started on statins stop taking them 13,14. Unfortunately, far too many people take statins and far too many prescriptions are dished out by GPs and specialists whom they trust but who do not read or understand the scientific literature and who have become the retail arm of the pharmaceutical industry.
One of the side effects of statin drugs is that they lower the levels of CoenzymeQ10 15. Coenzyme Q10 is not only required for energy production in cells, but also protects against free radicals by acting as an essential fat-soluble antioxidant. Clinical evidence also shows a beneficial effect of Coenzyme Q10 in cardiac arrhythmias, irregular heartbeats, and lowering the risk of heart attack 16. A recent study found Coenzyme Q10 (CoQ10) for treating people with severe heart failure reduced the mortality and morbidity by around 50%. In essence CoQ10 is essential for our health and is important in lowering the risks of heart attack or stroke and statin drugs lower levels of this essential nutrient.
Major side effects associated with statin drugs include muscle wastage including a form of muscle disease, rhabdomyolysis, that is fatal, memory loss and amnesia. Not only is cholesterol not the enemy but also it is essential to good health and wellbeing. Every cell in the body needs cholesterol in its membrane where it plays a critical role in cell communication. Without cholesterol, cell membranes are incomplete and as a result their functional role deteriorates.
Cholesterol is also used in the mitochondria, the powerhouse of the cell, and plays a vital role in cell energy production not to mention its essential role in the brain structure and function. Cholesterol is the starting material of many essential chemicals including vitamin D, steroid hormones and bile acids for digestion. Cholesterol is metabolised into vital body steroids such as the steroid hormones, these include: sex hormones, oestrogen, progesterone, testosterone and DHEA, as well as the adrenal hormones aldosterone and cortisol. When you lower cholesterol levels you reduce your production of your hormones. As a result statin use can induce gynecomastia, an abnormal enlargement of one or both breasts in men and the proliferation of the glandular component of the breast tissue 17.
Numerous studies have shown that cholesterol is an important part of your immune system. Low cholesterol levels have also been shown in studies to increase a person’s susceptibility to infections 18 This is due to cholesterol’s functional role in preventing infections in the body. The lipoproteins that carry cholesterol through our bloodstream aid in our protection against the harmful effects of bacterial endotoxins that are released during infection. Studies have also found cholesterol may have protective properties against some cancers 19.
Cholesterol is the most abundant organic molecule in the brain and is a vital component required for synapse function 20,21,22. In fact the person who discovered this essential role in the brain won a Nobel Prize in biochemistry. Cholesterol is also required for the function of serotonin receptors in the brain. Serotonin is the chemical in our brain that makes us feel happy. Cholesterol is a significant component of the cell membrane that influences its fluidity. It therefore indirectly affects neurotransmitters by interfering with their membrane bound receptors 23. It also forms part of the myelin that surrounds our nerves aiding in the fast transmission of nerve signals. Lower cholesterol levels in the blood are correlated with slower visuomotor speed 24 and has potential implications for some diseases like multiple sclerosis and motor neurone disease.
Statin statistics: lies and deception
Various independent studies in prestigious, peer-reviewed journals have shown that statin use in primary prevention—that is to prevent heart attacks—have minimal or no value in reducing mortality. It does not matter how one processes the statistics, the results just aren’t there. In data gathered in 2009 from six trials, a review of their ability to lower the risk of death with statins found virtually no difference between the treatment group who received the drug and the control group 25. And there are many more of these studies.
The problem really comes down to vested interests and the abuse of statistics. As readers of the scientific journals we should not get confused between statistical significance and clinical significance. Statistically significant means that the outcome was likely (95% chance) a result of the treatment whether it was 100% effective or less than 0.1% effective. That is, if you treat 1,000 people to save one life (0.1%) it may be statistically significant but it is not clinically significant. Clinical significance refers to the expectations doctors and patients have for the success of the treatment and is usually 30% or more. That is, if ten people get the drug at least three will benefit. The best studies on statins by the drug companies report statistical significance, mostly less than half of one percent usually around 0.3%, around 100 times less than our expectations of clinical significance and none at all have so far found any clinical significance. GPs just do not understand the difference between statistical and clinical significance. So if the professionals don’t understand how do we expect the media or public to understand?
Interestingly, the use of other cholesterol lowering drugs (non statins) that reduce cholesterol just as effectively as the statins don’t even reach clinical significance, that is they don’t even reach 0.1 percent. So we know the effect of the statins is not the effect of lowering cholesterol that gives the drugs their incredibly small but statistically significant 0.3% effect. Otherwise the other cholesterol lowering drugs would work at the same rate. As the statin drugs are a synthetic mimic of a natural cholesterol treatment, “red rice yeast,” which had been used successfully for decades before the drug companies patented the statins. Red rice yeast works just as effectively as the statins but with many fewer side effects. Red rice yeast also has small anti-inflammatory and anti oxidative properties. It seems the small benefit the statins have (0.3%) is because they act like nutrition. Not because they lower cholesterol.
The studies on statins also report relative risk not absolute or real risk. This really fools the GPs. The relative risk reduction is highly misleading and deceptive. An example of relative risk is if you have four people out of 1,000 in a study who die in the placebo group (no drug) compared to three people out of 1,000 who die in the drug treatment group, that is four were likely to die but only three did, then for most of us it is a change of 0.1% (1 in 1,000, not much) but when you use relative risks it shoots up to 25%. They compare three to four and say four is 25% higher than three so the relative risk is 25%. It is still only one person in 1,000 a reduction of 0.1% but the doctors who believe the drug companies obviously never mastered statistics. Relative risk is like adding 1+1 to get 11 or 2+5 to get 25 or more.
The well known JUPITER Study (which I like calling the STUPITOR study if you believe the sales hype) found that treatment with statins went from 68 heart attacks in the placebo group (no drug) to 31 heart attacks in the drug treatment group a 58% relative risk reduction and 64 strokes in the placebo group to 33 strokes in the treatment group a relative risk reduction of 48% 26. Sounds good doesn’t it? However, the drug treatment group had 8,901 participants in it. In real terms the heart attack risk went from a very low 0.76% to 0.35% and the risk of stroke went from 0.72% to 0.37%. That is, they had about a 0.35% reduction. Effectively if you treat 300 people with expensive and dangerous drugs you might save one life. Under the best possible scenario the real risk reduction was well under one half of one percent. Interestingly while the heart attack risk was reduced by around 0.35% the number of deaths increased with the drug use. Oops… no one reported this.
1. Kris-Etherton et al. 2002;
2. Wang et al. 2006;
3. Schacky and Harris 2006;
4. Psota et al. 2006;
5. Harris et al. 2006;
6. Robinson J.G. and Stone 2006;
7. Reiffel J.A. and McDonald 2006;
8. Jacobson 2006
9. Wierzbicki et al. 1999;
10. Nawrocki et al. 1995;
11. Bertolini et al. 1997;
12. Marz et al. 1999
13. Jackerviciua et al. 2002;
14. Benner et al. 2002
15. Folkers et al. 1990
16. Rosenfeldt et al. 2005
17. Romao 2007
18. Leardi S. et al. 2000
19. Goldstein et al. 2009
20. Mauch et al. 2001;
21. Koudinov and Koudinova 2001
22. Göritz et al. 2002
23. Heron et al. 1980
24. Zhang J. et al. 2004
25. Bartolucci et al. 2009
26. Ridker et al. 2008