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.