25/01/10 16:46 Filed in: Cardiovascular disease
by Dr. Walter Fernyhough, ND
Here we go on Cholesterol lowering drugs. Really were going to be talking about statin drugs here, since they are the big money makers for the pharmaceutical companies, and the big financial drain for the patients.
I wrote a general blog on research and information gathering last week, and promised to give you the goods on statins this week. It has been a busy week for me and I have been going through the research and information on statins when I can. I don’t remember if I mentioned it last week, but tracking down and going through the research is a big pain in the neck. It can also be expensive. Most of the research I just went through the abstracts, some I was able to obtain the journal articles for free, but one that I was particularly interested in investigating (I will tell you why in a moment), I had to purchase online. At first I went to a site where I thought I was buying the article, but it was only a paragraph explaining the outline of the study. It still cost me $31 US to buy the one paragraph outline. I then found the actual 7 page article which also cost me $31 US. You can see why I did not buy all the articles in order to review them. There are special journal articles called Meta analytical reviews. These are research studies, or actually a collection of research studies gathered by researchers on a single topic, in order to get a sort of average on the effectiveness of a drug or class of drug (in this case statin drugs). These are considered more powerful than a single study, since there are many problems that can occur with a single study. The researchers in a meta analysis review will generally spend a lot of time going through all the appropriate studies and excluding those that they deem to be biased or faulty in some way. I will go through the results of a meta analysis of statin drug therapy a little later in this blog.
Let’s start by seeing what the Heart and Stroke foundation of Canada and the American Heart association are saying.
From the Heart and Stroke Foundation of Canada website:“by lowering your cholesterol, you can dramatically [emphasis mine] reduce your risk of heart disease and stroke”.
But they also admit that:“Cholesterol is a vital building block of cell membranes, hormones, and vitamin D. Without it our bodies couldn’t function.”
I talked about this in my blog about cholesterol.
From the American Heart Association (AHA) website:
“High cholesterol is one of the major controllable risk factors for coronary heart disease, heart attack and stroke. As your blood cholesterol rises, so does your risk of coronary heart disease.”
Notice that the AHA does not make the bold statement of the Heart and Stroke Foundation of Canada that ‘you can dramatically reduce your risk of heart disease and stroke’ by lowering cholesterol. They don’t say this directly, but they infer it by writing ‘high cholesterol is one of the major controllable risk factors’.
Where is the Heart and Stroke Foundation of Canada and the AHA getting their information if I am saying the research does not show cholesterol lowering drugs can ‘dramatically reduce your risk of heart disease and stroke’. It’s all in the interpretation, misinterpretation, or false representation of the research. In order to show you the reality of cholesterol lowering drugs I have to drag you through the research (kicking and screaming). I will be as gentle as I can, mainly because I need to go gently for my own sanity. This means I am not going to go in to detail with the studies (some I don’t have all the details anyway) but I will pay special attention to the most favourable study towards statin use that was listed on the AHA website (this is the one that ended up costing me $62 US) and the more recent meta analysis (I told you I would get to it) on statin therapy. I may comment on the other less favourable studies listed on the AHA website, but I did not obtain the full text for these studies.
If you want more information on Cholesterol and Statin use there is an easy to read book called ‘Drugs that Don’t Work and Natural Therapies that do’ written by a Medical Doctor in the US called David Brownstein. He writes a series of informative books about Natural Medicine which can be found at www.drbrownstein.com. I don’t have any connections to Dr. Brownstein, other than I have read a few of his books and find them informative. I guess anyone that actually looks at the research will come to the same conclusions as Dr. Browntein and myself (and thousands of other healers) so it’s really just the same information I am giving you here, but if you need a second opinion, with different examples, and put in a slightly different way.
Anyway, let’s look at a study called the Scandinavian Simvastatin Survival Study (4S). The actual full name of the study paper is ‘Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). I’ll just refer to it a the 4S study from here on. The study included 4,444 people (obvious from the title) and went for a mean of 5.4 years (4.9 to 6.3 years). The subjects were men and women aged 35 to 70 years. The numbers quoted by the AHA and others who support statin use (found in the summary section of course) are as follows:
Relative risk of overall death in the simvastatin group was .70 (reported as a 30% reduction in overall death when taking simvastatin ... sounds pretty good)
Relative risk of coronary death (death due to a coronary event) in the simvastatin group was .58 (reported as a 42% reduction in coronary death when taking simvastatin ... sounds even better).
OK, let’s take a closer look at this study. First, this study is not a prevention study, meaning that all of the participants had a previous history of myocardial infarctions or angina. Second, most of the women were excluded from the study (‘premenopausal women of childbearing potential’ were excluded). 827 of the 4444 participants were women. So, this study can’t really be used to justify statin use in prevention (high cholesterol with no previous history of heart disease) or in women. In fact, there was a greater overall death rate in the women who were taking the drug, although this increase was small (relative risk of death in simvastatin group was 7.5% higher). But, why would women take a drug that increases their risk of death, no mater how small. And this is only in women who have had a previous history of heart disease. The increased risk of death by taking simvastatin in women with high cholesterol levels and no history of heart disease would be even greater (if they follow the trend of male studies). Anyways, back to the men and the overall results. The summary, and the AHA, is giving us the relative risk numbers, which can be confusing. If we look at the absolute risk reduction the numbers are a little less appealing. These are the numbers that most people consider they are getting when they read them on the AHA site or in the newspapers. The absolute risk reduction numbers are as follows:
Absolute risk of overall death in the simvastatin group was .96 (a 4% reduction in overall death when taking simvastatin ... doesn’t sound as good)
Absolute risk of coronary death in the simvastatin group was .957 (a 4.3% reduction in coronary death when taking simvastatin ... again, not so good)
This translates to 4 participants per 100 in the study that would be protected from dying during the 5.4 years of the study. This is actually pretty good. No other study has actually shown this benefit, which is why I picked this study to show you. It is also the reason you can’t just look at one study to reflect the true actions of a drug. Remember that this study does not show that simvastatin is helpful for women (it increases their risk of death) or in men without a history of heart disease (study only included those with previous history of angina or heart attack). Did I mention the study bias. Well, it was funded by Merck (the pharmaceutical responsible for simvastatin (a.k.a. Zocor)), was monitored by the Scandinavian subsidiaries of Merck, and the data analysis was performed by Merck. A financial disclosure (conflicts of interest) of the researchers were not given, which is odd, since most studies provide this information. We can only assume that the researchers are tied to Merck financially, and not just the financing for this study. In fact, a quick search on Google just now shows that the lead researcher is a speaker,consultant, and researcher for a handful of the pharmaceutical giants. Anyway, this is probably the best research that the pharmaceutical companies can buy. Let’s look at a better representation of the research now.
This study is a meta-analysis called “Primary Prevention of Cardiovascular Diseases With Statin Therapy: A Meta-analysis of Randomized Controlled Trials”. The authors of the study report no financial disclosure (no conflicts reported). This analysis of 7 studies included 90% with no history of CV disease. Most of those included in the study were male, though there were still a large number of females, and the mean age was >60. The mean study duration was 4.3 years. Ok, let’s get to the numbers.
Relative risk of overall death in the statin group was .92, but this was not significant (not significant does not mean a small amount here, it means that after statistically analyzing the numbers, the difference is no better than what could be attained by chance). This number, if it was significant, would represent an 8% reduction in overall mortality when taking simvastatin. If we look at the absolute risk reduction then it translates to about a 0.5% reduction in overall mortality. This is a miniscule amount (much different from the S4 trial) and, because it is not statistically significant, is reported as not shown to decrease the incidence of overall mortality. The relative risk reduction in coronary heart disease mortality was higher (a 22.6% reduction). The numbers needed to calculate absolute risk reduction were not given, but if you look at the S4 trial as an example then this 22.6% relative risk reduction would translate to a 2% reduction in coronary heart disease mortality. Again, this number was not statistically significant, so it is reported as not shown to decrease the incidence of coronary heart disease mortality.
So this meta-analysis of 6 major statin studies shows that the statin drugs did not decrease the incidence of overall mortality or mortality due to coronary heart disease. And is decreasing their risk of death not the reason people might suffer the side effects of statin drugs, such as muscle pains, muscle weakness, heart failure, brain fog, dementia,cancer, and depression, Statins are very effective at lowering cholesterol levels (not looked at in this meta-analysis), but this does not translate to decreased risk of death. They also seem to decrease the incidence of major coronary and cerebrovascular events, but this also does not translate to a decreased risk of death. Keep in mind that the majority of subjects in this meta-analysis had no history of cardiovascular disease, as opposed to the S4 study above. There has been a fairly consistent finding in men only, with a previous history of heart disease, that a statin may decrease the risk of coronary heart disease mortality. This number is usually quoted as an absolute reduction in risk of around 1% (not 4% as in the S4 study above). This means that women are not helped by taking a statin whether they have a history of heart disease or not (in fact, risk of death is increased), and men may only be helped by taking a statin if they have a history of heart disease, and not if they only have been diagnosed with high cholesterol. Oh yeah, men over 65 have not been shown to have a lower risk of death by taking a statin, whether they have a history of heart disease or not (except, of course, in a few industry sponsored and controlled studies such as the S4 study above).
When the Heart and Stroke Foundation of Canada writes, “by lowering your cholesterol, you can dramatically [emphasis mine] reduce your risk of heart disease and stroke”,
they are not technically lying, although they may be pushing it with the dramatically part. There is some evidence that you can reduce your risk of heart disease and stroke in certain circumstances and in certain people by lowering cholesterol levels. The evidence is not very convincing, however, when looking at a connection between lowering your risk of death and lowering your cholesterol levels, unless you are a woman and want to increase your risk of death, then statins are for you.
Here’s to your health.
03/01/10 19:45 Filed in: Cardiovascular disease
by Dr. Walter Fernyhough, ND
This will be the first on a series of blogs on Cardiovascular disease (CVD). The first time most people are told they are at risk for CVD is when their cholesterol levels are checked and they come back slightly high (or they have high blood pressure, something I will cover in a future blog). It is for this reason that I will start my series on CVD with a discussion about cholesterol.
First of all, cholesterol is not the cause of CVD. This is a very important concept to understand. There is a correlation (connection) between high cholesterol and CVD, but cholesterol is not the cause of CVD. I have repeated this a couple of times just to emphasize the fact, since the focus on cholesterol (by the media and medical associations) has most people believing that cholesterol is the cause of CVD. Here is another fact. Lowering cholesterol levels with drugs has never been shown to significantly lower the risk of developing heart disease or dying due to heart disease. I will talk more about these drugs in a later blog. For now it is more important to understand that lowering your cholesterol level has not been shown to lower your risk of developing CVD, and for someone that already has CVD, lowering your cholesterol level has not been shown to significantly lower your risk of having future cardiovascular problems (including death). In fact, studies have shown that people with a low cholesterol level have a greater risk of death than those with a high cholesterol level. Remember that I did say that there is a correlation between high cholesterol and CVD, which means that a higher than normal cholesterol level indicates that you are at an increased risk of CVD, but it is probably not the high cholesterol that is the cause for the increased risk. It is more likely that whatever caused the increase in cholesterol is also responsible for the increased risk of CVD. You see, it has been recognized for some time that excess cholesterol is probably being produced by the body in order to repair chronic damage, overcome a hormone deficiency, or for other reasons i will talk about later, and most of these disorders can cause an increased risk of CVD. I will talk more about these processes in a minute.
Cholesterol is necessary for every cell in the body, in fact, human life itself is not possible without it. The integrity of each and every cell membrane in the body is dependent on cholesterol, and it will become rigid and leaky without it. Cholesterol is also needed to produce all of the adrenal hormones. These hormones include DHEA, Progesterone, Cortisol, Testosterone, and Estrogen. Many diseases that we treat are due to deficiencies of these hormones, and these hormones deficiency diseases are devastating to the lives of those who suffer from them. An absence of certain of these hormones would mean death.
Your body does its best to keep these hormones at optimal levels, so when it detects a deficiency it tries to correct it. One of the first things it needs is the precursor for the hormone, and the precursor is cholesterol. The liver will therefore increase its production of cholesterol. If everything is working properly, the adrenal gland will take the extra cholesterol to produce more of the hormone it needs and thus correct the deficiency, and the cholesterol level will drop back to normal levels. If the cholesterol level stays elevated it is a sign that everything is not working properly. You see, this high cholesterol level is a sign of something wrong in the body, so we need to focus on the ‘wrong’ that caused the high cholesterol level, not just lower the cholesterol. Another reason that you might see higher than normal cholesterol levels is when there is damage occurring to the cells in the body. This damage could be due to oxidation by free radicals, inflammation, or a number of other factors. You generally will not detect a rise in cholesterol levels due an acute injury, but a chronic process will frequently cause an increase. In this case the liver is producing larger than normal amounts of cholesterol and circulating it through the blood stream in order to reach the site of injury to repair the damage to the cells (remember cholesterol is used in all the cells membranes). So, if we lower the cholesterol levels in the body using drugs, we do not prevent the chronic damage, we only inhibit the bodies ability to repair that damage. If the damage is occurring to the cells lining the blood vessels then we may slow the formation of plaques, but we inhibit the repair of the blood vessels at the same time. And remember, just lowering cholesterol does not significantly lower the risk of CVD or death. You may have noticed that I used the words “not significantly lower” a couple of times now when referring to lowering cholesterol levels and CVD instead of stating that it “absolutely does not lower” the risk. I am not trying to be sneaky using this phrasing, it just means that there have been studies that showed a very small benefit, but when you look at all the studies on lowering cholesterol this benefit is miniscule at best, and some even show that your risk of death will increase when you use drugs to lower your cholesterol levels. I will talk about this research in another blog on the cholesterol lowering drugs.
Cholesterol is not only important in cell membranes and adrenal hormone production. It is also needed for Vitamin D production, fat and vitamin absorption, optimal neurological function, optimal immune function, and CoQ10 production. Vitamin D is needed to maintain bone strength and immune function and a deficiency of vitamin D is linked to cancer. Cholesterol is the main ingredient in bile salts and bile salts are needed for the digestion of fat and fat soluble vitamins (A, D, E, and K). Cholesterol is part of the sheath that surrounds nerve cells (needed for conduction of nerve signals) and is necessary for neurotransmitter production in the brain (allows transmission of signals from one nerve cell to another). Low cholesterol is associated with low immunity and an increased risk of infection. Cholesterol is needed for CoQ10 production and CoQ10 is a crucial substance in energy production. The heart muscle contains the largest amount of CoQ10 which is needed due to the hearts huge demand for energy. People on cholesterol lowering drugs will become deficient in CoQ10 (unless they supplement) which may eventually lead to congestive heart failure.
Cholesterol is not the villain and is not the cause of CVD. If you look at the volumes of research, not just the abstracts of the research, or the summary that is carefully written by the drug industry and distributed to the media and drug reps, then you will see that cholesterol is a whipping boy of the drug companies, used to sell more cholesterol lowering drugs.
More on the research and the cholesterol lowering drugs in the next blog.
Until then ... here’s to your health.