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New Cholesterol Treatment Guidelines Could Double the Number of People on Dangerous Statins—Including Perfectly Healthy People

November 27, 2013 | 192,166 views
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By Dr. Mercola

One in four Americans over the age of 45 currently take a statin drug, despite the fact that there are over 900 studies proving their adverse effects, which run the gamut from muscle problems to increased cancer risk.

Now, new treatment guidelines for high cholesterol will likely DOUBLE the number of Americans being prescribed these dangerous drugs, bringing the total to an estimated—and staggering—72 million people!

The new guidelines, laid out in the report 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults1,2 were issued by the American Heart Association and the American College of Cardiology on November 12.

The updated treatment guidelines now focus on risk factors rather than cholesterol levels.

The guideline report was prepared by a panel of “experts” who volunteered their time, and is ostensibly based on an analysis of randomized controlled trials. Not surprisingly, the panel members are affiliated with more than 50 different drug companies, many of which have a financial interest in the outcome of this report. One of the authors even has stock in a medical malpractice firm.

According to the New York Times,3 several committee members ended up dropped out of this investigative panel because they were “unhappy with the direction the committee was going.”

How May the New Guidelines Affect You?

As explained by the American Heart Association,4 the new guidelines advise doctors to look at certain risk factors in order to determine if a patient should be prescribed a statin drug, or whether he or she should simply focus on heart healthy lifestyle changes. The problem is, virtually no one will fall into the latter category.

If you answer “yes” to ANY of the following four questions, the treatment protocol calls for a statin drug:

  1. Do you have heart disease?
  2. Do you have diabetes? (either type 1 or type 2)
  3. Is your LDL cholesterol above 190?
  4. Is your 10-year risk of a heart attack greater than 7.5 percent?

The calculation to ascertain your 10-year heart attack risk was developed by a committee chaired by Dr. Donald Lloyd-Jones. He explained the cardiovascular risk calculator,5 to CNN:6

"We were able to generate very robust risk equations for both non-Hispanic white men and women as well as African-American men and women. Those equations factor in age, sex, race, total and HDL ('good') cholesterol levels, blood pressure levels, blood pressure treatment status as well as diabetes and current smoking status. Each of those factors is assigned a numerical value and can be used to determine individual risk percentage using an online calculator.”

Well-Known Integrated Cardiologist Decimates Treatment Guidelines

Dr. Stephen Sinatra7 wrote an in-depth article in which he decimates every single one of these four treatment guidelines. According to him, the new guidelines are at best 20-25 percent accurate, and here’s why:

  1. The heart disease criteria, while it might be appropriate for older men, does not really work for women. There’s no data demonstrating that the benefits of statins outweigh the health risks in women—risks that include diabetes and breast cancer.
  2. According to Dr. Sinatra: “[I]n my opinion, the only women who should be on statins are those with advanced coronary artery disease who continue to deteriorate despite lifestyle interventions. I believe that less than one percent of women with coronary artery disease fall into this category.”

  3. In short, giving a drug that causes diabetes to someone who already has diabetes is nonsensical. It can only make matters worse. What’s more, data indicates that statins can cause arterial calcification in diabetic men who take the drug. Thirdly, statins can cause cataracts, which is a common problem in diabetics. The drug may therefore increase this risk.
  4. This may be appropriate if you have genetic familial hypercholesterolemia, as this makes you resistant to traditional measures of normalizing cholesterol, such as diet and exercise. This condition is quite rare, affecting an estimated one in 500. In the absence of this genetic situation, treating high LDL levels has little validity.
  5. As you will see below, the 10-year heart attack risk calculation has been “programmed” in such a way as to make patients out of virtually everyone. Besides that, Dr. Sinatra points out that the complexity of estimating risk based on age, race, blood pressure, smoking habits and other criteria is quite likely to lead to overzealous prescribing.

The CV Calculator—‘A Major Embarrassment'

The CV risk calculator, which basically evaluates those who do not immediately qualify by having heart disease, diabetes or elevated LDL, appears to have some very significant flaws. And again, not surprisingly, the flaws are such that a vast majority of people end up having a greater than 7.5 percent risk of a heart attack within the next 10 years—thereby qualifying them for “preventive” statin treatment.

A very clever strategy indeed: create a test that virtually assures that everyone who takes it will be a candidate for these expensive drugs they’re seeking to have people take for the rest of their lives. According to a November 17 article in the New York Times,8 Dr. Steven Nissen (quoted earlier) spoke out against the implementation of these guidelines:

“[I]n a major embarrassment to the health groups, the calculator appears to greatly overestimate risk, so much so that it could mistakenly suggest that millions more people are candidates for statin drugs. The apparent problem prompted one leading cardiologist, a past president of the American College of Cardiology, to call... for a halt to the implementation of the new guidelines.

‘It’s stunning,’ said... Dr. Steven Nissen... “We need a pause to further evaluate this approach before it is implemented on a widespread basis.’ ‘We’re surrounded by a real disaster in terms of credibility,’ said Dr. Peter Libby, the chairman of the department of cardiovascular medicine at Brigham and Women’s Hospital.”

...The controversy set off turmoil at the annual meeting of the American Heart Association... After an emergency session... the two organizations that published the guidelines — the American Heart Association and the American College of Cardiology — said that while the calculator was not perfect, it was a major step forward, and that the guidelines already say patients and doctors should discuss treatment options rather than blindly follow a calculator.”

Using the CV Calculator Virtually Guarantees You’ll Be Put on a Statin

As it stands, the guideline committee has vowed to examine the flaws to determine if and what changes are needed to make it more accurate. Until then, it may be good to know that the calculator appears to overestimate your risk by anywhere from 75 to 150 percent! Dr. Nissen used the calculator to evaluate some of his own patients—men who had no known risk markers. They had healthy cholesterol levels, normal blood pressure, and didn’t smoke; in short, men who were completely healthy, and found they still ended up having a 7.5 percent risk, qualifying them for arbitrary drug treatment.

“Something is terribly wrong,” he told the New York Times,9 noting that using this calculator will ensure that virtually every “average healthy Joe” gets statin treatment. According to the two researchers who discovered the problem:10

“Miscalibration to this extent should be reconciled and addressed before these new prediction models are widely implemented. If real, such systematic overestimation of risk will lead to considerable overprescription.”

But that’s not all. As described by the American Heart Association,11 the guideline also does away with the previous recommendation to use the lowest drug dose possible—a strategy that typically meant you’d end up being prescribed a low-dose statin along with one or more other cholesterol-lowering medications. The new guideline basically focuses ALL the attention on statin-only treatment, and at higher dosages, ostensibly to eliminate the need for additional drugs. But if you don’t need ANY drug to begin with, why take a much higher dose of a drug that is well known for having potentially serious side effects?!

Statins Are Hardly Preventive Medicine

The panel members have concocted a bizarre justification for these actions, trying to make it sound like the new recommendations are focused on prevention through lifestyle modifications along with statin therapy. This is a gross misapplication of the word “prevention,” as these drugs cannot address the underlying conditions of heart or cardiovascular disease. Even more egregious, they have apparently chosen to completely ignore recent research showing that statins can effectively negate the benefits of exercise, which is one of the primary heart disease prevention strategies!

But the biggest “sham” of all is that statin drugs, touted as “preventive medicine” to protect your heart health, can actually have detrimental effects on your heart. For example, a study published just last year in the journal Atherosclerosis,12 showed that statin use is associated with a 52 percent increased prevalence and extent of calcified coronary plaque compared to non-users. And coronary artery calcification is the hallmark of potentially lethal heart disease. Just what kind of prevention is that?

Statins Shown to Nullify Benefits of Exercise

One of the major benefits of exercise is the beneficial impact it has on your heart health, and exercise is a primary strategy to naturally maintain healthy cholesterol levels. Alas, if you take a statin drug, you’re likely to forfeit any and all health benefits of your exercise. As previously reported by the New York Times:13

In past studies, researchers have shown that statins reduce the risk of a heart attack in people at high risk by 10 to 20 percent for every 1-millimole-per-liter reduction in blood cholesterol levels (millimoles measure the actual number of cholesterol molecules in the bloodstream), equivalent to about a 40-point drop in LDL levels.

Meanwhile, improving aerobic fitness by even a small percentage through exercise likewise has been found to lessen someone’s likelihood of dying prematurely by as much as 50 percent... But until the current study, no experiment scrupulously had explored the interactions of statin drugs and workouts in people. And the results, as it turns out, are worrisome.”

The study, published in the Journal of the American College of Cardiology,14 discovered that statin use led to dramatically reduced fitness benefits from exercise, in some cases actually making the volunteer LESS fit than before. The results showed that:

  • On average, unmedicated participants improved their aerobic fitness by more than 10 percent after a 12-week long (five days a week) supervised exercise program. Mitochondrial content activity increased by 13 percent
  • Volunteers taking 40 mg of simvastatin improved their fitness by a mere 1.5 percent on average, and some had reduced their aerobic capacity at the end of the 12-week fitness program. Mitochondrial content activity decreased by an average of 4.5 percent

According to senior study author John P. Thyfault, a professor of nutrition and exercise physiology at the University of Missouri:15 “’Low aerobic fitness is one of the best predictors’ of premature death. And if statins prevent people from raising their fitness through exercise, then that is a concern.”

How Statins Might Undo Fitness Benefits and Make Your Heart Health Worse

The key to understanding why statins prevent your body from reaping the normal benefits from exercise lies in understanding what these drugs do to your mitochondria—the energy chamber of your cells, responsible for the utilization of energy for all metabolic functions.

The primary fuel for your mitochondria is Coenzyme Q10 (CoQ10), and one of the primary mechanisms of harm from statins in general appears to be related to CoQ10 depletion. This also explains why certain statin users in the featured trial ended up with worse aerobic fitness after a steady fitness regimen.

It's been known for many decades that exercise helps to build and strengthen your muscles, but more recent research has revealed that this is just the tip of the iceberg when it comes to the potential role exercise can play in your health. A 2011 review published in Applied Physiology, Nutrition and Metabolism16 pointed out that exercise induces changes in mitochondrial enzyme content and activity (which is what they tested in the featured study), which can increase your cellular energy production and in so doing decrease your risk of chronic disease.

Are New Guidelines a Shrewd Way to Promote Statins Without Blaming Cholesterol?

Odds are greater than 100 to 1 that if you're taking a statin, you don't really need it. The ONLY subgroup that might benefit are those born with a genetic defect called familial hypercholesterolemia, as this makes them resistant to traditional measures of normalizing cholesterol. For many years, I’ve been educating my readers about the fact that cholesterol isn’t the cause of heart disease, and even conventional doctors have started catching on. So I can’t help but wonder if these new guidelines, which bypass the issue of cholesterol levels, placing the focus on risk factors instead, aren’t just a shrewd way of getting around this pesky issue.

Now, in three out of four cases, your cholesterol levels will not be a factor at all—you still qualify for statin treatment just by having heart disease, diabetes or a 7.5 percent or greater 10-year risk, based on a calculator that makes patients out of completely healthy people. This truly appears to be a recipe for disaster, and I cannot advise against falling into this trap strongly enough. It reminds me of the ludicrous suggestion three years ago to provide free statins with meals at fast food restaurants.17

Special Warnings for Statin Users

Statins are HMG-CoA reductase inhibitors, which means they act by blocking the enzyme in your liver that is responsible for making cholesterol (HMG-CoA reductase). But remember, your body NEEDS cholesterol—it is important in the production of your cell membranes, hormones, vitamin D, and bile acids that help you to digest fat. Cholesterol also helps your brain form memories and is vital to your neurological function. There is also strong evidence that having too little cholesterol INCREASES your risk for cancer, memory loss, Parkinson's disease, hormonal imbalances, stroke, depression, suicide, and violent behavior.

As I mentioned earlier, there are over 900 studies demonstrating the harmful effects of statins. To learn more about statins, please see my special report: “Do YOU Take Any of These 11 Dangerous Cholesterol Drugs?” It’s also important to remember that statins are classified as a "pregnancy Category X medication" meaning, it causes serious birth defects, and should NEVER be used by a woman who is pregnant or planning a pregnancy.  If it is prescribed it is simply gross negligence and malpractice.

Another factor to keep in mind is that statin drugs may not mix well with other potentially lifesaving drugs, such as antibiotics. According to recent Canadian research,18 patients —especially the elderly—taking cholesterol-lowering drugs such as Lipitor, should avoid the antibiotics clarithromycin and erythromycin, as these antibiotics inhibit the metabolism of statins. Increased drug concentrations in your body may cause muscle or kidney damage, and even death.

Statin Drugs Can Wreck Your Health in Multiple Ways

Statins have also been shown to increase your risk of diabetes via a number of different mechanisms, so if you weren’t put on a statin because you have diabetes, you may end up with a diabetes diagnosis courtesy of the drug. Two of these mechanisms include:

  • Increasing insulin resistance, which can be extremely harmful to your health. Increased insulin resistance contributes to chronic inflammation in your body, and inflammation is the hallmark of most diseases. In fact, increased insulin resistance can lead to heart disease, which, again, is the primary reason for taking a statin in the first place. It can also promote belly fat, high blood pressure, heart attacks, chronic fatigue, thyroid disruption, and diseases like Parkinson's, Alzheimer's, and cancer.
  • Raising your blood sugar. When you eat a meal that contains starches and sugar, some of the excess sugar goes to your liver, which then stores it away as cholesterol and triglycerides. Statins work by preventing your liver from making cholesterol. As a result, your liver returns the sugar to your bloodstream, which raises your blood sugar levels.

Drug-induced diabetes and genuine type 2 diabetes are not necessarily identical. If you're on a statin drug and find that your blood glucose is elevated, it's possible that what you have is just hyperglycemia—a side effect, and the result of your medication. Unfortunately, many doctors will at that point mistakenly diagnose you with "type 2 diabetes," and possibly prescribe another drug, when all you may need to do is simply discontinue the statin in order for your blood glucose levels to revert back to normal.

Statin drugs also interfere with other biological functions. Of utmost importance, statins deplete your body of CoQ10, which accounts for many of its devastating results. Therefore, if you take a statin, you must take supplemental CoQ10, or better, the reduced form called ubiquinol. Statins also interfere with the mevalonate pathway, which is the central pathway for the steroid management in your body. Products of this pathway that are negatively affected by statins include:

  • All your sex hormones
  • Cortisone
  • The dolichols, which are involved in keeping the membranes inside your cells healthy
  • All sterols, including cholesterol and vitamin D (which is similar to cholesterol and is produced from cholesterol in your skin)

New Guidelines Fraught with Massive Conflicts of Interest

The authors of the guideline list conflicts of interest, starting on page 51 of the document, but it’s been reported that anyone with conflicts did not actually vote on the final draft. Some news outlets have therefore reported that there were NO conflicts of interest involved in the making of the guidelines. This is, I believe, a serious mistake in reporting, as members of this panel actually have ties to more than 50 different drug companies. Whether they voted on the final draft or not, they were still instrumental in creating the guidelines in the first place.

For example, the lead author, Dr. Neil J. Stone, is a strong proponent of statin usage and has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo. He’s also served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.  Here are two more examples:

  • The second author listed, Jennifer Robinson, admitted to the New York Times in 2011 that she was taking research money from seven companies, including some top sellers of cholesterol pills. University of Iowa records show industry financing of more than $450,000 for research led by Robinson between 2008 and 2011. (As an FYI, 2008 was the year the committee began working on these new treatment guidelines.)
  • Another author, C. Noel Bairey Merz, has received lecture honoraria from Pfizer, Merck & Kos, and has served as a consultant for Pfizer, Bayer, and EHC (Merck). She’s also received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging, as well as a research grant from Merck. She also has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

12 of 16 Panel Members have Ties to Drug Industry

Two years ago, the New York Times19 criticized the cholesterol panel, including Dr. Stone, for its many apparent conflicts of interest. Stone told the NYT that the group was taking “extraordinary measures to reduce bias,” but with the evidence I've found on this group, how could they possibly not be biased toward the use of statins? At least 12 of the 16 members have financial ties with the pharmaceutical industry!   Even more egregious, only seven of them chose to disclose such ties. After hours of internet research, I discovered five more authors had potential conflicts of interest with industry. It's nothing short of outrageous that an entire nation of people may be prescribed these hazardous drugs based on the decision by a group that has so many financial ties to so many drug companies.

The panel’s conflicts of interest again came under fire in a recent article in Time Magazine,20 which noted that:

“The Institute of Medicine (IOM), an independent organization of scientists that analyzes available data and provides advice on medical issues, recommends that chairs of guideline committees should have no conflicts of interest if possible, and that the entire panel should also be free of ties to industry; if that’s not possible, then at least half of the members should meet this criterion...

Those policies stem from studies suggesting that biases do creep into people’s behaviors, whether consciously or not. In one study published earlier this year, for example, scientists compared the guidelines proposed by two different groups of experts for treating a blood clotting disorder; the panel in which 73% of members reported connections to pharmaceutical companies suggested stronger recommendations for turning to drug-based treatments compared to a panel in which none of the members had ties to industry.”

Dr. Stone claims the panel could not have been created unless members with conflicts of interest were included, because anyone involved in a statin drug trial would be considered a consultant. “And you can’t have expertise without having done clinical trials,” he told Time. However, according to the IOM, panels charged with devising treatment guidelines do NOT really have to be experts in the field. While helpful, clinical experience is not critical because the job of the panel is to assess available research for sound methodology and accuracy of data.

On Living a Heart Healthy Lifestyle

Contrary to what pharmaceutical PR firms will tell you, statins have nothing to do with reducing your heart disease risk. In fact, this class of drugs can increase your heart disease risk—especially if you do not take Ubiquinol (CoQ10) along with it to mitigate the depletion of CoQ10 caused by the drug.

Poor lifestyle choices are primarily to blame for increased heart disease risk, such as eating too much sugar, getting too little exercise, lack of sun exposure and rarely or never grounding to the earth. These are all things that are within your control, and don’t cost much (if any) money to address.

The fact that statins can effectively nullify the benefits of healthy lifestyle changes like exercise, which in and of itself is important to bolster heart health and maintain healthy cholesterol levels, is yet another reason to think twice before opting for such a drug. Also remember that the BEST way to condition your heart (as well as burn excess fat) is to engage in high-intensity interval exercise. Evidence suggests that this may actually provide MORE protection against heart attacks than long durational aerobic-type exercises.

If you’re currently taking a statin drug and are worried about the excessive side effects they cause, please consult with a knowledgeable health care practitioner who can help you to optimize your heart health naturally, without the use of these dangerous drugs.

[+] Sources and References