Study Reveals Statins Not Very Effective or Safe

March 18, 2015
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Statistical Deception Creates the ‘Appearance’ That Statins Are Safe and Effective

A new report published in the Expert Review of Clinical Pharmacology concluded that statin advocates used a statistical tool called relative risk reduction (RRR) to amplify statins’ trivial beneficial effects.¹

The directors of clinical trials, according to the report, have also succeeded in minimizing the significance of a large number of adverse effects of statin treatment.

So how are statistics being used to deceive you about statins’ effectiveness? If you look at absolute risk, statin drugs benefit just 1 percent of the population. This means that out of 100 people treated with the drugs, one person will have one less heart attack.

This doesn’t sound so impressive… so statin supporters use a different statistic called relative risk. Just by making this statistical slight of hand, statins suddenly become beneficial for 30-50 percent of the population.

As for side effects, the report notes that side effects are more common than the media and medical conferences report, and the modest benefits of the drugs do not even come close to outweighing the risks, which included increased rates of:

Cancer
Cataracts
Diabetes
Cognitive impairment
Musculoskeletal disorders

The study authors noted:²

“In the Jupiter trial, the public and healthcare workers were informed of a 54 percent reduction in heart attacks, when the actual effect in reduction of coronary events was less than 1 percentage point…

In the ASCOT-LLA study, which was terminated early because it was considered to have such outstanding results, there were heart attacks and deaths in 3% of the placebo (no treatment) group as compared to 1.9% in the Lipitor group.

The improvement in outcome with Lipitor treatment was only 1.1 percentage point, but when this study was presented to the public, the advertisements used the inflated (relative risk) statistic, which transformed the 1.1% effect into a 36% reduction in heart attack risk.

The inflated claims for statin effectiveness, and minimized portrayal of the adverse effects, has played a role in the health care providers and the public's enthusiasm for cholesterol-lowering drugs, say the authors.”

A Quick Brush-Up On Your Statistics May Make Your Mouth Drop Open

I want to highlight just how drastic a difference statistics can make, and how drug companies can legally deceive you by stating effectiveness in terms of relative risk.

Absolute risk reduction is the decrease in risk of a treatment in relation to a control treatment. Relative risk reduction is calculated by dividing the absolute risk reduction by the control event rate.

In plain English, here's what that means: let's say you have a study of 200 women, half of whom take a drug and half take a placebo, to examine the effect on breast cancer risk.

After five years, two women in the drug group develop breast cancer, compared to four who took the placebo. This data could lead to either of the following headlines, and both would be correct:

"New Miracle Drug Cuts Breast Cancer Risk by 50%!"

"New Drug Results in 2% Drop in Breast Cancer Risk!"

How can this be? The Annie Appleseed Project explains:³

"The headlines represent two different ways to express the same data. The first headline expresses the relative risk reduction — the two women who took the drug (subjects) and developed breast cancer equal half the number (50%) of the four women who took the placebo (controls) and developed breast cancer.

The second headline expresses the absolute risk reduction — 2% of the subjects (2 out of 100) who took the drug developed breast cancer and 4% of the controls (4 out of 100) who took the placebo developed breast cancer — an absolute difference of 2% (4% minus 2%)."

You can now see why clinical trials, especially those funded by drug companies, will cite relative risk reductions rather than absolute risk reductions, and as a patient you need to be aware that statistics can be easily manipulated. As STATS at George Mason University explained:⁴

"An important feature of relative risk is that it tells you nothing about the actual risk."

Statin Drugs Stimulate Atherosclerosis and Heart Failure

Are you ready for another shocker? A separate study published in Expert Review of Clinical Pharmacology revealed that, in contrast to the current belief that cholesterol reduction with statins decreases atherosclerosis, the drugs may instead actually stimulate atherosclerosis and heart failure.⁵

There were several physiological mechanisms discussed in the study that show how statin drugs may make your heart health worse:⁶

Inhibit vitamin K2 function: Vitamin K2 protects your arteries from calcification. Without it, plaque levels worsen. Statin drugs inhibit the function of vitamin K2 in your body.
Mitochondria damage: Statins are toxic to the energy centers of your cells, called mitochondria. They impair heart muscle mitochondria function, disrupt ATP production (adenosine triphosphate (ATP), the energy molecules of your body), and alter intracellular signaling proteins.⁷
Interfere with coenzyme Q10 (CoQ10): Statins deplete your body of CoQ10, which accounts for many of their devastating results. Although it was proposed to add a black box warning to statins stating this, the US Food and Drug Administration (FDA) decided against it in 2014.
Interfere with selenium-containing proteins: Selenoproteins such as glutathione peroxidase are crucial for preventing oxidative damage in your muscle tissue. As reported by Wellness Resources:⁸

“Blocking the selenoprotein enzyme glutathione peroxidase is akin to pouring gasoline on the fire of inflammation and free radicals, which damages muscle tissue. In fact, the scientists described this blocking of the selenoproteins reminiscent of selenium deficiency induced heart failure, known as Keshan’s disease first identified in the 1930s.”

Considering the significant risks, the authors concluded:⁹“...the epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically reevaluated.”

They Don’t Work for Parkinson’s Disease Either

Stain makers have attempted to position them as some sort of panacea for many diseases, one of which is Parkinson’s disease. Past research by Xuemei Huang, professor of neurology and vice chair for research at Penn State College of Medicine, suggested a link between high cholesterol levels and lower rates of Parkinson’s, yet some epidemiological evidence suggested a lower risk of Parkinson’s associated with statin use. In a new study conducted by Huang and colleagues, he attempted to find out if the lowered incidence of Parkinson’s could indeed be due to statins.

The results? Statins were not protective of Parkinson’s and, instead, were associated with an increased risk.¹⁰ Further, high total cholesterol and LDL were associated with a lower risk of Parkinson’s disease. The study concluded, “Statin use may be associated with a higher PD [Parkinson’s disease] risk, whereas higher total cholesterol may be associated with lower risk.” As for why past studies may have shown a link between statins and a lower Parkinson’s risk, Huang suggested:¹¹

“One possibility, is that statin use can be a marker of people who have high cholesterol, which itself may be associated with lower [Parkinson's] risk. This could explain why some studies have found an association between use of these medications and low incidence of [Parkinson's]. Most importantly, this purported benefit may not be seen over time."

If You Take Statins, Be Sure You’re Taking CoQ10 or Ubiquinol

If you do decide to take a statin drug, you need to make sure you take CoQ10 or Ubiquinol (the reduced form) with it. Most are not told they need to take coenzyme Q10 to buffer against some of the most devastating side effects of the drug. As previously explained by Dr. Stephen Sinatra, a board-certified cardiologist, statins block not just cholesterol production pathways, but several other biochemical pathways as well, including CoQ10 and squalene—the latter of which Dr. Sinatra believes is essential in preventing breast cancer.

Squalene reduction caused by the statin can also raise your risk of immune system dysfunction. The depletion of CoQ10 caused by the drug is why statins can increase your risk of acute heart failure. So if you're taking a statin drug, you MUST take Coenzyme Q10 as a supplement. You cannot get enough of it through your diet. Dr. Sinatra recommends taking at least 100 milligrams (mg), but preferably 200 mg of high-quality CoQ10 or Ubiquinol daily. One study in the European Journal of Pharmacology showed that ubiquinol effectively rescued cells from the damage caused by the statin drug simvastatin, thereby protecting muscle cells from myopathies.¹²

Another study evaluated the benefits of CoQ10 and selenium supplementation for patients with statin-associated myopathy.¹³ Compared to those given a placebo, the treatment group experienced significantly less pain, decreased muscle weakness and cramps, and less fatigue. Keep in mind, however, that there’s a very good chance you may not need a statin drug at all. If you’ve been told you need to take a statin, please read these 7 factors to consider if you’re told your cholesterol is too high.

Are You at Risk for Heart Disease?

Total cholesterol will tell you virtually nothing about your disease risk, unless it's exceptionally elevated (above 330 or so, which would be suggestive of familial hypercholesterolemia, which, in my view, would be about the only time a cholesterol-reducing drug would be appropriate). Two ratios that are far better indicators of heart disease risk are:

Your HDL/total cholesterol ratio: HDL percentage is a very potent heart disease risk factor. Just divide your HDL level by your total cholesterol. This percentage should ideally be above 24 percent. Below 10 percent, it's a significant indicator of risk for heart disease
Your triglyceride/HDL ratios: This ratio should ideally be below 2

Additional risk factors for heart disease include:

Your fasting insulin level: Any meal or snack high in carbohydrates like fructose and refined grains generates a rapid rise in blood glucose and then insulin to compensate for the rise in blood sugar. The insulin released from eating too many carbs promotes fat and makes it more difficult for your body to shed excess weight, and excess fat, particularly around your belly, is one of the major contributors to heart disease
Your fasting blood sugar level: Studies have shown that people with a fasting blood sugar level of 100-125 mg/dl had a nearly 300 percent increase higher risk of having coronary heart disease than people with a level below 79 mg/dl
Your iron level: Iron can be a very potent oxidative stress, so if you have excess iron levels you can damage your blood vessels and increase your risk of heart disease. Ideally, you should monitor your ferritin levels and make sure they are not much above 80 ng/ml. The simplest way to lower them if they are elevated is to donate your blood. If that is not possible you can have a therapeutic phlebotomy and that will effectively eliminate the excess iron from your body

How to Optimize Your Cholesterol Levels

The goal of the guidelines below is not to lower your cholesterol as low as it can go, but rather to optimize your levels so they're working in the proper balance with your body. The majority of your cholesterol is produced by your liver, which is influenced by your insulin levels. Therefore, if you optimize your insulin level, you will tend to automatically optimize your cholesterol. This is why my primary recommendations for safely regulating your cholesterol have to do with modifying your diet and lifestyle as follows (what you won’t find on this list is taking cholesterol-lowering medication or eating a low-cholesterol diet):

Reduce, with the plan of eliminating, grains and sugars in your diet. It is vitally important to eliminate gluten-containing grains and dangerous sugars especially fructose until your insulin resistance resolves.
Consume a good portion of your food raw.
Make sure you are getting plenty of high-quality, animal-based omega 3 fats, such as krill oil. Research suggests that as little as 500 mg of krill per day may improve your total cholesterol and triglycerides and will likely increase your HDL cholesterol.
Replace harmful vegetable oils and synthetic trans fats with healthy fats, such as olive oil, butter, and coconut oil (remember olive oil should be used cold only, use coconut oil for cooking and baking).
Include fermented foods in your daily diet. This will not only optimize your intestinal microflora, which will boost your overall immunity, it will also introduce beneficial bacteria into your mouth. Poor oral health is another powerful indicator of increased heart disease risk.
Optimize your vitamin D levels, ideally through appropriate sun exposure as this will allow your body to also create vitamin D sulfate—another factor that may play a crucial role in preventing the formation of arterial plaque.
Exercise regularly. Make sure you incorporate high-intensity interval exercises, which also optimize your human growth hormone (HGH) production.
Avoid smoking or drinking alcohol excessively.
Be sure to get plenty of high-quality, restorative sleep.