Statin deception – the drugs don’t work

by michael

statin drugs

This article is a continuation from the last couple of articles on cholesterol, it was researched by Dr. Peter Dingle and explains some of the research behind cholesterol lowering drugs. It is a long article but an important one if you or someone in your family is on cholesterol medication.

Millions of Australians are prescribed cholesterol-lowering drugs, called statins, such as Pravachol, Zocor and Lipitor each year at a cost of more than one billion dollarswith very little if any benefit and lots of negative side effects. Despite the media hype from poor and lazy journalism in Australia and the public relations campaigns of big drug companies, at best these drugs lower the actual risk of heart attack or stroke by less than one percent and at the same time have serious side effects in up to 5% of the population of users. Unfortunately, far too many people take statins and far too many prescriptions are dished out by GPs who do not read or understand the scientific literature or are too busy and who have simply become the retail arm of the pharmaceutical industry.

The first real hint that something is wrong is that the majority of what we know about statins and their effects (beneficial or otherwise) actually comes directly from the scientific trials themselves, which were funded by and even coordinated by the drug companies not from long-term, independent, evidence-based observations. As a result, all the information we have received is strongly biased.

The cholesterol-lowering program used during the past 30 years has in large part failed to stem the epidemic of cardiovascular disease. At the same time, the focus on cholesterol reduction has deflected interest in other therapeutic aspects of inflammation treatment that provide significantly greater benefit. It has been known now for 30 years that despite significant Low Density Lipoprotein-cholesterol (LDL-C) reduction, large numbers of subjects in the drug treatment groups continue to have heart attacks and strokes despite achieving significant LDL-C reduction. This myopic focus on LDL alone is not surprising given the vested interests of the pharmaceutical industry but it has distracted us from the real problem. As highlighted in last month’s article, cholesterol is not the notorious substance that it is made out to be, it is just the messenger. Despite this, the statin drugs do have a very small benefit of reducing the risk of heart attack or stroke. One of these effects that is non-related to lipid lowering is to stimulate nitric oxide (NO) in the arteries which has numerous positive effects on the arteries and blood vessels. A number of foods such as almonds can also achieve this outcome. The only other scientifically proven action of statins is their capability of lowering blood levels of C-reactive protein (CRP), a marker of inflammation in the body, and a major risk factor for heart disease. Raised CRP levels and raised cholesterol levels in the blood are both the symptoms of an underlying problem but like cholesterol it is not the cause.

Therefore, the reasons that some studies have found statins to bring about a very small “real” reduction in the risk of CVD may not be attributed to the reduction in the notorious blood cholesterol level but rather its effects on nitric oxide and its action as an anti-inflammatory agent. Unfortunately for the drug companies there are many very cheap and natural ways to reduce inflammation and improve the nitric oxide levels, most of which involve healthy food and lifestyle changes.

Statin therapy is extremely efficient in lowering cholesterol numbers but unfortunately not without adverse effects on the body. To prevent a first heart attack, for every life that is saved, 1% over 10 years of use, statins cause an equal number of adverse deaths due to accidents, infection, suicide and cancer: 1% over 10 years use and significantly greater levels of serious side effects and suffering.

Because statins interfere with major biochemical pathways they have serious side effects. Statins inhibit the production of many other vital substances as well as cholesterol. A recent review on the adverse effects of these drugs cited more than 900 studies. Statin drugs block Coenzyme Q10 which is an essential enzyme involved in energy production and also acts as an essential fat soluble antioxidant. CoEnzyme Q10 plays a vital role protecting the heart and cardio vascular system and is our natural defense against atherosclerosis development, the build up of plaque in the arteries that leads to cardiovascular disease. Coenzyme Q10 inhibits the oxidation of LDL cholesterol, inappropriate clotting of the blood and ultimately lowers blood pressure.

Statin treatment may also lead to serious muscle toxicity. At least 5% to 7% of statin users experience significant muscle problems more than 10% if higher doses are taken and as many as 25% of statin users who exercise may experience muscle fatigue, weakness, aches, and cramping due to statin therapy. This defeats the purpose when those with elevated risk of heart attack or stroke find it hard to exercise.

Statins have also been implicated as negatively impacting brain function. Cholesterol is the most abundant organic molecule in the brain. The housekeeping functions in the brain, synapse function. and serotonin all rely on cholesterol produced in the brain because it is too large to pass through the blood-brain barrier. Unfortunately, the statin drugs can easily pass into the brain and directly interfere with the synthesis of cholesterol in the brain. No wonder a major side effect of the statin drugs is their impact on memory and thinking. Amnesia is a known adverse effect from taking Lipitor. A study by the drug company Pfizer found two percent of people taking Lipitor have serious amnesia. Ironically, the Amnesia was only recognized if it was remembered and observed and reported by the study participants. Many people recorded memory blanks and forgetfulness, but this was not considered as amnesia in the study. Even so the two percent is at least 385 times more likely than the general population to have amnesia.

In a study to see the effects of raising the Lipitor levels from 10 to 80 mg {more sales} on patients, those taking 80mg had increased liver problems i.e. raised liver enzymes, was six times higher than those given 10mg of Lipitor. Even though the total deaths due to CVD in the 80mg group was less {126} than the 10mg group {155}, the total deaths due to other causes was higher in the 80mg {158} than the 10mg {127} group. There was no difference in the overall mortality rate.

If they have so many side effects, and far too many for me to describe here, what are the benefits? While there are many wild and exaggerated claims and a lot of hype about the benefits of statins there are almost as many studies showing no benefits at all. This is brought about by the misuse of statistics. Various independent studies in prestigious peer reviewed scientific journals have shown that statin use in primary prevention, that is no previous history of a heart attack or stroke, have minimal or no value in reducing mortality. To quote one of the papers “primary prevention with statins provides only small and clinically hardly relevant improvement of cardiovascular morbidity/mortality. Another review found current clinical evidence does not demonstrate that titrating lipid therapy to achieve proposed low LDL cholesterol levels is beneficial or safe. So why are we using them and why are doctors so caught up in the drug scam?

As a reader 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 1000 people to save one life (0.1%) it may be statistically significant but it is not clinically significant. Clinical significance is 20 to 30% or more. The studies on statins report statistical significance, mostly 1% or less, and none at all have so far found any clinical significance. So they should not be used.

The studies on statins also report relative risk not absolute or real risk. The relative risk reduction is highly misleading if not deceptive. An example of relative risk is where if you have 4 people in a study who die in the placebo group (no drug) compared to 3 people who die in the drug treatment group, that is 4 were supposed to die but only 3 did, then there is a 25% relative risk reduction. However, to get this effect of saving one life you had to treat 1000 people the real risk reduction is 0.1%. Relative risk is like adding 1 plus one to get 11 or more.

A well known study The JUPITER Study found that treatment with statins went from 68 heart attacks in the placebo group 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%. Sounds good doesn’t it? However, the drug treatment group had 8901 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%. 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. The real risk reduction of consuming a handful of raw mixed nuts is around 30% and a relative risk reduction of more than 600%. So why are we using these drugs?

More recently, a meta-analysis of 10 randomized clinical trials of about 70,000 people with risk factors for cardiovascular disease but no history of existing disease had a relative risk reduction of 12% for total mortality, 30% for coronary event and 19% for a cerebrovascular event. However, the real risk reduction was 0.6%, 1.3% and 0.4% respectively. The actual number of people needed to treat to save one life was 167.

It is not just the scientists jumping up and down over the misuse of statistics and drugs but also the health economists are continually questioning the reason for so much statin treatment. In an economic review of statin use the authors reported that it is not cost effective to treat low risk people. A recent study in the UK found statins in primary prevention cost 27 828 per life-years gained (LYG), reaching 69 373 per LYG in men aged 35-44 34. That is to add one year to a persons life they need to spend 69 373 (around Aus$125000) per year, and reported that “amounts of NHS funding are being spent on relatively less cost-effective interventions, such as statins for primary prevention”. Perhaps you might say that every life is worth that. Unfortunately, it is a big economic price to pay and one we cannot afford. On the positive side nutrition and lifestyle changes can bring about much greater real benefits and at much lower costs, but not when people think drugs are the only solution.

In a brief summary of all this the dugs just don’t work. Thank you to Dr. Peter Dingle for this article.

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