Let’s go on a little journey. Imagine if you will the following situation. A US pharmaceutical company, always on the outlook for ways to improve people’s lives, creates a drug that is exceptionally good at treating patients with chronic and acute pain particularly in cases of arthritis. The drug is submitted to and approved by the US Food and Drug Administration (FDA), that bastion of public protection, created to protect and promote public health. The drug gains worldwide acceptance among physicians who are treating patients with chronic pain. Over 80 million people worldwide prescribed the drug at some time. The pharmaceutical company has sales revenues of $2.5 billion in the fourth year of its acceptance because of its amazing success. This is clearly a story of the system working correctly, no? The research and development of a drug that is widely accepted, approved safe by the governmental agency designed to protect the public from rogue agents has to be a great success story.
Unfortunately that’s not the case. The drug described above is Vioxx. After 5 years on the market, it was voluntarily withdrawn by Merck after data in multiple studies showed that there was a dose-dependent increased risk of myocardial infarctions (heart attacks) among users of Vioxx. Over the course of its 5 year usage, it is estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 % of which were fatal. There is some evidence that Merck either withheld data or reported it in a suspiciously favorable way that showed an increased rate of overall mortality from the FDA. At the very least, what we have here is an incident where a major pharmaceutical company had a drug that was exceptionally profitable. That drug was on the market for 5 full years before anyone managed to notice that it was definitely causing an increase in cardiovascular events and possible reducing the overall mortality of people taking it long term. The system does not protect us and can be easily manipulated by those most likely to profit.
This incident occurred through the usage of selective reporting of data in studies sponsored by the pharmaceutical company. Unfortunately, this is the norm in our current health environment. Studies and study authors are often directly sponsored by the pharmaceutical industry. Many times, the study data is directly interpreted by the industry. Since it is in their interest to present their products in the most positive light possible, it should come as no surprise that an incident like the Vioxx one came to be.
As it turns out, it’s entirely possible that another incident is ongoing except that it is 10 times as large as the Vioxx one above. Statins are a class of cholesterol lowering drug that had total sales revenues in 2009 of over $25 billion. They are led by atorvastatin (Lipitor) with a sales revenue in 2008 of $12.4 billion. The current thinking in the health industry today is that cholesterol is associated with cardiovascular disease (CVD) and thus, statins are prescribed to lower cholesterol in an effort to lower the risk of CVD. Unfortunately, the evidence to support such a conclusion is mixed at best and quite possibly not supportive of the conclusion at all.
That’s the thesis of the book The Great Cholesterol Con. The book’s author, Dr. Malcolm Kendrick, goes into great detail about the studies that have been used to support the cholesterol causes heart disease theory. He very clearly shows that the data is not nearly as ironclad as the pharmaceutical industry says, especially as it relates to cholesterol causing heart disease.
The main principle under discussion is the Diet-Heart Hypothesis which says that if you eat too many foods with saturated fat and cholesterol, the level of cholesterol in your blood will rise which will be deposited in the arterial walls causing them to thicken and harden which over time will lead to a heart attack or stroke due to a blockage in one of the arteries. This has been the main hypothesis for heart disease for many years. Unfortunately, it’s completely wrong.
It is Dr. Kendrick’s assertion that the hypothesis is flawed in two ways. First, the level of cholesterol in your blood has nothing to do with what you eat. The second, and more important, is that that doesn’t matter because cholesterol doesn’t cause heart disease. In support of the first point, the book uses a two pronged approach in support. The first is an analysis of what happens in individuals who have Smith-Lemli-Optitz Syndrome (SLOS) which is a an abnormally low cholesterol level. If you go to the above link, you’ll see that having abnormally low levels of cholesterol is horribly bad for us. And yet, we are being prescribed medicines by the millions to artificially lower our cholesterol. The second prong is explaining what the body actually uses cholesterol for. As it turns out, cholesterol is in high demand in the body, such high demand that you can’t possibly eat enough cholesterol to provide your body with the requisite amount. So the liver synthesizes 4 to 5 times the amount you eat just to keep up. If you eat less cholesterol, your liver has to make more. If you eat more, your liver makes less. This is called downregulation. It makes no sense at all that by eating less saturated fat and cholesterol, we’ll have less of it in our bloodstream because the liver is always going to produce the amount the body needs to function properly.
Regarding the idea that cholesterol and saturated fat don’t cause heart disease, Dr. Kendrick presents multiple examples of instances where either the saturated fat and cholesterol intake of populations drop but the rates of heart disease increase or vice versa. The two main studies here examine the effects of rationing on WWII Britain and the French Paradox. In WWII Britain, rationing forced the population of the UK to eat much less saturated fat and more vegetables and fish were eaten. During the 12 years this happened, the rate of heart disease trebled. The French Paradox is obviously one that most people are aware of. The French eat lots of meat, lots of cheese, lots of things that, if the diet-heart hypothesis were true, should mean an increase in heart disease across the population. Instead, the French actually have a much lower incidence of heart disease relative to other populations. There is other evidence presented in the book but these two alone provide data that how we are treating heart disease is wrong.
Returning to statins, the book argues that statins actually act not through a cholesterol lowering mechanism but through some other as yet unknown mechanism. Several studies are presented that show statins have an effect on heart disease regardless of cholesterol level in the study participants. In other words, even if you already have a low cholesterol level, statins occasionally protect you from heart disease. The presents a problem in the theory that the cholesterol lowering effects of the statin are responsible for the lower incidence of heart disease. Dr. Kendrick does believe that statins have some positive effect on the incidence of heart disease but that it is not because they lower cholesterol and the evidence he presents is compelling.
However, while you might be thinking that since they have a positive effect, it shouldn’t matter whether they act on cholesterol or some other mechanism, the reality of the situation is much less positive. Here are three facts supported by multiple studies concerning statins:
- Statins do not reduce overall mortality in women.
- Statins do not reduce overall mortality in men without heart disease.
- Statins do not, therefore, reduce overall morality in >95% of the adult population.
What does all that mean? It means that even if you take statins and even if they reduce the incidence of heart disease, overall mortality is unaffected in 95% of the population. In other words, taking a statin will change what they write on your death certificate under “Cause” but the “Date” portion will remain unchanged. That means that while statins lower the incidence of death by heart disease, they increase the incidence of death by other factors. What you get out of years of paying through the nose for a statin prescribed to prevent heart disease is not a longer life but just a different kind of death.
Additionally, statins have a list of side effects and contraindications long enough to scare practically anyone that reads them closely. Remember how the body needs cholesterol to function properly? There are multiple incidences of people taking statins who suddenly have acute memory loss. This would make sense because one of the uses the body has for cholesterol is in the brain synapses. Statins are known to cause muscle pain and even rhabdomyolysis. The reduction of cholesterol in pregnant women may lead to very serious birth defects. The list goes on and on. And yet there are leading “experts” out there who think we might ought to put statins in the drinking water.
The pharmaceutical industry has a vested interest to the tune of over $25 billion in revenues in keeping statins at the forefront of the fight against heart disease even though it is abundantly clear that they have an almost negligible effect on overall mortality. This book goes into great detail the problems with statins, their minimal benefit to the greater part of the population and the grave dangers that are being overlooked in the widespread use of them. As in the Vioxx case, just because the pharmaceutical industry and the FDA says it’s good for you doesn’t actually mean it is. If you are on a statin or have been told by your doctor that you should be taking one, you owe it to yourself to read this book to see what you’re actually getting yourself into.