Statin Disaster

Is everything so rosy with statins? I say the answer is an easy and loud, “NO!” Statins are the most profitable medications in the history of Big Pharma, despite failing nearly 99 percent of patients who take them. Since over 25 million Americans currently take a daily statin medication, that’s a lot of failure. The statin drug hype is a perfect example of what is wrong with conventional medicine. Let me explain.

Statins are a class of medications that lower cholesterol levels. They work by poisoning the enzyme HMG CoA reductase, which is found in all cells. Conventional medicine would have you believe (erroneously) that cholesterol is a dangerous substance and that elevated cholesterol levels are causing plaques in the coronary arteries and, by extension, heart attacks. But in fact, every single cell in the human body needs and requires an optimal amount of cholesterol in order to function. We simply cannot live without adequate cholesterol levels.

I am continually amazed at how slick the pharmaceutical industry is to convince both the public and many physicians that statins should be prescribed to the majority of Americans. They have declared that heart disease, our number one killer, is due to elevated cholesterol levels and that we must reduce our cholesterol levels to prevent becoming heart patients.

I call this thought process the cholesterol = heart disease hypothesis. In other words, most conventional doctors would be happy to tell you that a lowered cholesterol level is always better than a higher level as it will lower your risk for heart disease. The cholesterol = heart disease hypothesis is taught in every medical school and treated as truth. In order to understand how this happened, I need to go back in time to provide the history of how the cholesterol = heart disease hypothesis originated.

It was started in the early 20th century by a Russian researcher, Nikolay Anichkov, MD, PhD, who fed cholesterol to rabbits and observed that the rabbits developed atherosclerotic plaques in their arteries. These atherosclerotic plaques were similar to the way human atherosclerotic plaques appeared on autopsy. Dr. Anichkov proclaimed that elevated cholesterol levels were responsible for producing atherosclerosis in humans.

What was not publicized was that a few years after Anichkov had reported his findings, other researchers showed that feeding rabbits iodine along with cholesterol prevented the atherosclerotic findings from the previous studies. In fact, the effects of iodine in preventing atherosclerotic plaques in animals were reproduced and similar results were reported in the literature four times. I have written extensively about this in my book, Iodine: Why You Need It, Why You Can’t Live without It.

My research has shown a direct correlation between lowered iodine levels and the development of heart disease. Furthermore, low iodine intake can result in elevated cholesterol levels. In my practice, I have found that over 96 percent of 6,000 patients have low iodine levels. Perhaps the reason we are still seeing heart disease as our number one killer is because conventional medicine has missed the underlying cause: iodine deficiency.

The cholesterol = heart disease hypothesis gained momentum in the 1960s when an American researcher, Ancel Keys, PhD, published a now-famous “Seven Countries Study” whereby he showed the risk and rates of heart attacks were directly related to the dietary fat intake and the level of total serum cholesterol. Dr. Keys’ study was carried out from 1958 to 1970 and is still shown to all medical students 42 years later. We are still experiencing the adverse effects of Dr. Keys’ study as illustrated by the widespread use of cholesterol-lowering medications.

However, what is little reported is that Dr. Keys may have committed scientific misconduct by failing to report all the data he had available to him. You see, at the time Dr. Keys published his “Seven Countries Study,” he had data from 22 countries available to him. Dr. Keys cherry-picked the seven countries that would validate his hypothesis that mortality from heart disease was directly related to dietary fat intake and cholesterol levels. When all the data from the 22 countries was evaluated, researchers reported that there was no correlation between the amount of dietary fat intake and the mortality from heart disease. Perhaps, if Dr. Keys had truthfully presented all the data he had available to him, we would not have wasted so much time and energy on lowering cholesterol levels with medications.

Statistics and Statins

How does Big Pharma convince nearly all medical doctors and lay people that everyone needs to take a statin medication? The answer is simple. First, they scare people with the idea that if you don’t take a statin medication, you will get a heart attack. Next, they manipulate statistics in order to convince everyone that statin medications are beneficial to take.

Big Pharma reports all statin studies using a relative risk analysis. The relative risk simply refers to risk of an event or developing a disease relative to exposure. I would estimate that Big Pharma evaluates a drug’s effectiveness by using the relative risk analysis in order to report their results. The problem is that a relative risk analysis can exaggerate the effectiveness of a drug or therapy.

A more accurate statistic is the absolute risk difference. In deciding whether to recommend a therapy or not, the absolute risk difference is more clinically important than relative risk differences. Nearly all drug articles fail to calculate the absolute risk difference; therefore it is up to the reader to calculate the information on their own. I would estimate that over 99 percent of doctors are unable to calculate the absolute risk difference when reading a medical article.

Another statistic that is important is the Number Needed to Treat (NNT). The NNT estimates the number of patients that need to take a drug in order for just one to get the desired effect. You can only calculate this number if you calculate the absolute risk difference first. The NNT is important, as a drug that needs to treat 2 people to get desired result is much different than a drug that needs to treat 100 to get the desired result. Think about it; if I prescribe a drug to 100 patients and only one gets the desired result, the drug failed 99 percent of the patients. That is not a good drug.

Most statin studies show the number needed to treat to be between 100 and 300. That means 100 to 300 patients need to take a statin drug to prevent a single cardiovascular event such as a heart attack. In other words, 99 to 299 patients received no benefit, yet were exposed to possible adverse effects and had to pay for the prescription.

The 2009 JUPITER study illustrates my point. This study evaluated 17,802 healthy subjects who had no prior cardiac history to see if statin drugs were helpful in preventing cardiac disease in a healthy population. The subjects were randomized to receive either the statin drug Crestor or a placebo. When the results were announced, the accompanying articles stated that JUPITER was such a success that it was the first study to indicate that healthy people should be given statin medications. The new cholesterol-lowering guidelines that I mentioned earlier were based, in part, on JUPITER. There was a 50-percent relative risk reduction in heart attacks in the Crestor treated group, when they were compared to the placebo group. Due to the results of JUPITER, sales of Crestor increased over $1.15 billion dollars in the third quarter of 2009.

The absolute risk difference and NNT were not reported in the article. The authors of the article—9 of 14 who had financial ties to the sponsor—only reported their data in a relative risk format. When I received the article, I calculated that, to prevent a heart attack, the absolute risk difference between the two groups was 0.41 percent. The NNT was 244 (1/0.41 percent) which means that, according to JUPITER, 244 patients need to take Crestor for 1.9 years (the length of the study) in order to prevent one heart attack. In other words, the drug failed 99.9 percent (243/244). How do I summarize JUPITER? That’s easy. It is another study, amongst many, that shows the failure of statin drugs in preventing heart disease in the vast majority who take them. Big Pharma sees it differently; they tout a 50 percent reduction in heart attacks.

Adverse Effects of Statin Drugs

Statins work by poisoning the HMG CoA reductase enzyme. Looking at the biochemical pathways can lead anyone to predict what will happen when this pathway is poisoned. Poisoning the HMG CoA enzyme will lower cholesterol levels. The brain (including the central and peripheral nervous systems) contains the highest concentration of cholesterol in the body. Guess which organ is particularly harmed by low cholesterol? If you guessed the brain and nervous systems, you win the prize.

Brain fog, dementia, depression, Parkinson’s disease, memory loss, neuropathy, and ALS are all documented adverse effects of statin use. This should be no surprise because lowering cholesterol levels in the brain and nervous system could be predicted to have disastrous effects. There have been 13,290 reports of depression and 9,044 cases of memory impairment and transient amnesia to the FDA Adverse Event Reporting System (FAERS) in regards to statins.

Statins are also associated with muscle disorders, as not only cholesterol production is inhibited by statins but so is the vitamin-like substance coenzyme Q10 (CoQ10). The highest concentration of CoQ10 is found in the muscles of the body. Now you can probably guess the adverse effects, but they include muscle pain, musculoskeletal stiffness and tightness, and congestive heart failure. Congestive heart failure is characterized by a weakness of the heart muscle to pump adequate amounts of blood to the tissues. It is increasing at epidemic rates and I have no doubt this is due to statin use, particularly by the elderly.

Statin drugs are bankrupting our medical system for a minuscule benefit. When you understand the adverse effects associated with statins and their cost, it becomes clear this class of medications needs to be pulled from the marketplace. One day, the history of medicine will reveal the horrors of prescribing too many ineffective and toxic medications—and statins will be at (or near) the top of the pile. I cannot understand how doctors can prescribe such a worthless class of medications to so many unsuspecting patients.

 

By David Brownstein, MD

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