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  • Controversial revised cholesterol-treatment guidelines loosened the definition of who would qualify for statin drug treatment to prevent heart disease, greatly increasing the number of people who would be eligible for treatment
  • Compared with the older guidelines, the new recommendations would increase the number of US adults eligible for statin therapy from 43.2 million to 56 million, with most of the increase occurring among adults without heart disease
  • The new guidelines advise doctors to look at certain risk factors in order to determine if a person should be prescribed a statin drug, but the risk factors are misguided, and the new guidelines are at best 20-25 percent accurate, according to experts
  • Statin drugs, touted as “preventive medicine” to protect your heart health, can actually have detrimental effects on your heart as well as other serious health risks
  • There are far better ways to prevent heart disease than taking statins, including eating right, exercising, and maintaining healthy vitamin D levels
 

New Cholesterol Guidelines May Put 13 Million More on Statin Drugs

April 02, 2014 | 95,445 views
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By Dr. Mercola

Cholesterol-lowering statin drugs are among the most widely prescribed drugs on the market, with one in four Americans over 45 taking them. This already inflated number is set to increase significantly, however, courtesy of controversial revised cholesterol-treatment guidelines issued by the American Heart Association (AHA) and the American College of Cardiology (ACC) last year.

The guidelines were met with fierce debate because they loosened the definition of who would qualify for statin drug treatment to prevent heart disease, greatly increasing the number of people who would be eligible for treatment.

The guidelines, which previously focused on cholesterol levels, now focus on risk factors, as determined by a flawed online calculator that may not accurately gauge heart-disease risk at all.

Adding to the debate, researchers from Duke University have calculated exactly how many more Americans may find themselves eligible for statin drugs under the less strict guidelines… and the results are astounding.

Half of Older Adults Should Take Statins Under New Guidelines

Using data from the National Health and Nutrition Examination Surveys of 2005 to 2010, the researchers estimated the number of people for whom statin therapy would be recommended under the new ACC-AHA guidelines.1

Compared with the older guidelines, the new recommendations would increase the number of US adults ages 40 to 75 eligible for statin therapy from 43.2 million to 56 million, with most of the increase occurring among adults without heart disease. This equates to nearly half of the US population between the ages of 40 and 75!

Among older adults (those between the ages of 60 and 75), the percentage eligible for statins would increase from 30 percent to 87 percent among men and from 21 percent to 54 percent among women. According to the study, this drastic rise would be driven largely by risk determined solely by their 10-year risk of a cardiovascular event – a measure that has been heavily criticized by experts (as I'll discuss shortly).

The study's lead author noted that this implies "if you're a 60- to 75-year-old man and not on a statin, you should go get one, and every other woman of this age should get one."2

In short, the new guidelines would increase those eligible for statins in the US by 12.8 million, with most of the rise seen in older adults without heart disease. As reported in the New England Journal of Medicine:3 

"…the new guidelines would recommend statin therapy for more adults who would be expected to have future cardiovascular events (higher sensitivity) but would also include many adults who would not have future events (lower specificity)."

Risk Factors That Suggest You Need a Statin, According to the New Guidelines

The new guidelines advise doctors to look at certain risk factors in order to determine if a person 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. 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. As for what risk factors necessitate statin drug treatment… 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 calculator created to ascertain your 10-year heart attack risk has been programmed in such a way as to make patients out of virtually everyone—health status or cholesterol levels be damned. The cardiovascular risk calculator appears to overestimate your risk by anywhere from 75 to 150 percent!4



According to Dr. Stephen Sinatra, who wrote an in-depth article in which he decimated every single one of these four treatment guidelines,5 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, as the calculator claims to do, is quite likely to lead to overzealous prescribing.

When Cleveland Clinic cardiologist Dr. Steven Nissen used the calculator to evaluate some of his own patients—men who had no known risk markers—it became clear just how flawed this measure really is. They had healthy cholesterol levels, normal blood pressure, and didn't smoke; in short, these were men who were completely healthy.

The calculator still ended up finding a 7.5 percent risk, qualifying them for arbitrary drug treatment. "Something is terribly wrong," he told the New York Times,6 noting that using this calculator will ensure that virtually every "average healthy Joe" gets statin treatment.

An Expert Take on the Guidelines' Major Flaws

When I interviewed Dr. Sinatra in 2011, he explained his position that statin drugs may be suitable for some people, but he agrees that the risks are very high, and side effects grossly underreported. In his recent response to the updated statin-treatment guidelines.  He stresses that the recommendations are only "partially true and exaggerate the benefits of statin drugs."7 According to him, the new guidelines are at best 20-25 percent accurate, in part due to the flawed 10-year risk assessment calculator and in part due to the following flaws with the suggested risk factors:

  1. Do You Have Heart Disease? The heart disease criterion, 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. 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."
  2. Do You Have Diabetes? 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.
  3. Is Your LDL Above 190? 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.

Dr. Sinatra summed it up well with the notion that statin drugs should not, in any way, be viewed as a form of prevention.

"…remember that there's no data to suggest statin medications will improve longevity even in people with cardiovascular disease—so I would never recommend using statins as primary prevention. Every patient is different, and prescribing a drug with an enormous side-effect profile based on an algorithm concept is, frankly, poor medicine. Doctors need to treat individuals with smart medicine—not guidelines, numbers and unproven myths and dogma." 8

Statins May Be Detrimental to Your Heart, and Overall, Health

Perhaps 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 in the journal Atherosclerosis9 showed that statin use is associated with a 52 percent increased prevalence and extent of calcified coronary plaque compared to non-users. Coronary artery calcification is the hallmark of potentially lethal heart disease!

Even more egregious, recent research shows that statins can effectively negate the benefits of exercise, which is one of the primary heart disease prevention strategies! The study, published in the Journal of the American College of Cardiology,10 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, non-medicated 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

Exercise induces changes in mitochondrial enzyme content and activity (which is what they tested in the above-mentioned study), which can increase your cellular energy production and in so doing decrease your risk of chronic disease. 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 "powerhouse" of your cells, responsible for the production of energy for all metabolic functions.

A 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. Therefore, if you take a statin, you must take supplemental CoQ10 or, better, the reduced (electron rich) form called ubiquinol. Statins also interfere with the mevalonate pathway, which is the central pathway for the steroid hormone production 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)

Statins have also been shown to increase your risk of diabetes via a number of different mechanisms, including increasing insulin resistance and raising your blood sugar. And this is only a handful of statin side effects. There are over 465 studies proving their adverse effects, which run the gamut from muscle problems and sexual dysfunction to cognitive loss and increased cancer risk.11

Conflict of Interest Casts Even More Doubt on the Guidelines' Validity

Anytime you have the potential for new guidelines that can increase the number of prescription drug users in the US by millions, you can bet the drug companies will want to weigh in… and weigh in they did. The authors of the guidelines 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. This is actually irrelevant, as 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.
  • 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.

Heart Disease Is Not the Result of a Statin 'Deficiency'

It's a slippery slope when we begin to put stock in medications as the "key" to preventing lifestyle-based diseases like heart disease. I do not foresee the end result of medicating virtually every adult American being a good one... It is obvious to anyone that understands natural health that this is a disaster in the works, as the evidence of harm from statins is overwhelming. Statins have nothing to do with reducing your heart disease risk. In fact, as mentioned 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, are safe (i.e. no side effects), and don't cost much (if any) money to address. If you want to prevent heart disease, you basically need to do the converse of what conventional medicine tells you. Resist falling for the hype that you need drugs to keep your heart healthy. There are far better ways. In short, to prevent heart disease:

  • DO eat unprocessed saturated animal and vegetable fats, and don't listen to the media, as you can benefit profoundly from consuming them. Many may also benefit from increasing the healthful fat in their diet to 50-85 percent of daily calories
  • AVOID all sugars, including processed fructose and grains, if you are insulin and leptin resistant. It doesn't matter if they are conventional or organic, as a high-sugar diet promotes insulin and leptin resistance, which is a primary driver of heart disease
  • DO exercise regularly, as physical activity along with a healthy diet of whole, preferably organic, foods may be just as potent—if not more potent—than cholesterol-lowering drugs. High-intensity interval training, which requires but a fraction of the time compared to conventional cardio, has been shown to be especially effective  
  • AVOID statins, as the side effects of these drugs are numerous, while the benefits are debatable. In my view, the only group of people who may benefit from a cholesterol-lowering medication are those with genetic familial hypercholesterolemia. This is a condition characterized by abnormally high cholesterol, which tends to be resistant to lowering with lifestyle strategies like diet and exercise

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