26 Aug Statins’ Flawed Studies and False Advertising
By Dr. Mercola
At your next doctor’s check-up, your visit will likely include a discussion of your risk of heart disease, your cholesterol levels, and whether or not you would benefit from taking a statin cholesterol-lowering drug.
In the US, guidelines issued in 2013 state that if you answer “yes” to ANY of the following four questions, your treatment protocol will call for a statin drug:
- Do you have heart disease?
- Do you have diabetes? (either type 1 or type 2)
- Is your LDL cholesterol above 190?
- Is your 10-year risk of a heart attack greater than 7.5 percent?
Your 10-year heart attack risk involves the use of a cardiovascular risk calculator, which researchers have warned may overestimate your risk by anywhere from 75 to 150 percent — effectively turning even very healthy people at low risk for heart problems into candidates for statins.
The guideline also does away with the previous recommendation to use the lowest drug dose possible and instead basically focuses ALL the attention on statin-only treatment and at higher dosages. With guidelines like these, it’s no wonder one in four Americans over the age of 40 currently take a statin drug – but are these drugs really beneficial?
Flawed Studies Call into Question Statins’ Effectiveness, Safety
Originally, statin drugs were prescribed for secondary prevention, meaning the prevention of a second heart attack or stroke if you’d already suffered one and had clear signs of heart disease.
But today a majority of people taking the drugs are doing so for primary prevention, i.e. “preventive medicine” – to help prevent people with certain risk factors of heart disease – although otherwise healthy – from having a heart attack or stroke in the first place.
This switch came largely as the result of flawed studies that hyped statins’ effectiveness while downplaying the risks. Among the first was the ASTEROID trial, published in 2006.1 It found that the high-dose statin drug Crestor led to significant reductions in plaque volume with no unusual side effects. However, as reported by the Institute of Science in Society:2
“It was the cross-sectional areas of atheroma [arterial plaque] that were compared before and after treatment, as it was assumed that these measurements were directly proportional to their volumes and that the area of the lumen [the inside of an artery] would show a corresponding increase.
However, what was not discussed in either the press releases or the article was that the lumen area actually decreased by 4%, and… the images also showed that the arterial wall had thickened. This might not be beneficial because a smaller lumen and a stiffer arterial wall would both tend to increase blood pressure, an effect also not addressed in the published report.
The Comments section conclusion said, ‘This very intensive statin regimen was well tolerated.’ But the total dropout rate appears to have been 25%; no details were provided to explain that.
Also, the trial may have been too short for the Crestor side effects reported in other studies to have surfaced, raising questions about long-term safety with this large daily dose that would have to be taken perpetually. In addition, there were no controls and only 349 patients.”
Landmark Statin Study Was Flawed
Shortly after the ASTEROID trial came the JUPITER study, which was published in the New England Journal of Medicine in 2008.3 It boasted that statin drugs could lower the risk of heart attack by 54 percent, the risk of stroke by 48 percent, the risk of needing angioplasty or bypass surgery by 46 percent, and the risk of death from all causes by 20 percent.
The funding for this study came from none other than AstraZeneca, the maker of statin drug Crestor – and once again, we find that industry-funded claims of health benefits for highly profit-producing drugs need to be viewed with a healthy dose of skepticism. The Institute of Science in Society reported:4
“The lead author is a co-holder of the patent for the hsCRP test used, which became the standard method of measurement at $50.00/test. Nine of the 14 authors had significant financial ties to AstraZeneca, whose investigators also collected, controlled, and managed the raw data and monitored the collection sites.
It is well established from other drug company sponsored studies that bias can creep in, such as the preponderance in the placebo group of patients with a family history of heart disease or metabolic syndrome, both of which significantly increase risk.”
Further, statin advocates used a statistical tool called relative risk reduction (RRR) to amplify statins’ trivial beneficial effects.5 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 to 50 percent of the population. In one study the authors noted:6
“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…”
JUPITER Trial Stopped Inexplicably Early…
The study was also stopped early for unexplained reasons, which, as was pointed out in an accompanying editorial:
“[P]rovides inflated estimates of benefits, understates harms, allows findings to be published (and hence used to advantage in marketing) earlier, and reduces the cost of the trial – all significant benefits to an industry sponsor and a financially invested research team.“7
Little note was made of the fact that the JUPITER trial also showed a 25 percent increased risk of new-onset diabetes in the treatment group… and this was detected even though the trial was ended early.
Then, two years after the original study came out, three articles were published in the Archives of Internal Medicine, refuting the claims laid down by the industry-funded JUPITER study.
One of these studies carefully reviewed the methods and the results of the JUPITER trial and concluded it was flawed and the results “do not support the use of statin treatment for primary prevention of cardiovascular diseases…”8
In addition, a second study, a meta-analysis of 11 randomized controlled trials, found no evidence to back up the JUPITER trial claim that statins can reduce your risk of death when used as primary prevention against heart disease.9
Do Statins Increase Your Risk of Breast Cancer?
Statin drugs work by blocking the enzyme in your liver that is responsible for making cholesterol. Yes, your liver makes cholesterol because you need cholesterol and it is essential for your very survival.
Cholesterol helps produce cell membranes, and in addition it also plays a role in the production of hormones (including the sex hormones testosterone, progesterone, and estrogen) and bile acids that help you digest fat.
Cholesterol is also essential for your brain, which contains about 25 percent of the cholesterol in your body. It is critical for synapse formation, i.e. the connections between your neurons, which allow you to think, learn new things, and form memories…
Statin drugs are effective and do to lower cholesterol, but as your levels fall you may assume that is proof that you’re getting healthier, that you’re becoming well. But that would be far from the truth.
There is far more that goes into your risk of heart disease than your cholesterol levels… and there is evidence showing that statins may actually make your heart health worse.
In addition, as 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.
Research has shown that long-term statin use (10 years or longer) more than doubles women’s risk of two major types of breast cancer: invasive ductal carcinoma and invasive lobular carcinoma.10
In addition, the use of any statin drug, in any amount, was associated with a significantly increased risk for prostate cancer in a separate study, and there was an increasing risk that came along with an increasing cumulative dose.11
Not to mention, statins increase your risk for many other serious side effects as well. They inhibit the function of vitamin K2 in your body, which means taking them may put you at risk of vitamin K2 deficiency, a condition known to contribute to a number of chronic diseases, including:
Osteoporosis Heart disease Heart attack and stroke Inappropriate calcification, from heel spurs to kidney stones Brain disease Cancer
Statins also deplete your body of CoQ10, which accounts for many of their devastating results. So if you’re taking a statin drug, you simply MUST take coenzyme Q10 or ubiquinol as a supplement. You cannot get enough of it through your diet.
New Guidelines Call for More Teens to Be Placed on Statin Drugs
Even teens and young adults are now being placed on statins. In 2011, the US National Heart, Lung, and Blood Institute (NHLBI) issued new guidelines for reducing heart disease in children and adolescents, recommending statin treatment if cholesterol levels are at a certain level.12,13 Meanwhile, the American College of Cardiology (ACC) and American Heart Association (AHA) have far tighter restrictions on the use of statins in those under the age of 40. According to a recent study, if doctors follow the NHLBI’s guidelines, nearly half a million teens and young adults between the ages of 17 to 21 will be placed on statins.14 As reported by Medicine Net:15
“Gooding’s team found that 2.5 percent of those with elevated levels of ‘bad’ low-density lipoprotein (LDL) cholesterol would qualify for statin treatment under the NHLBI cholesterol guidelines for children, compared with only 0.4 percent under the ACC/AHA adult guidelines. That means that 483,500 people in that age group would qualify for statin treatment under the NHLBI guidelines, compared with 78,200 under adult guidelines…
It’s common for abnormal cholesterol levels and other heart disease risk factors to start appearing when people are teens, but the two sets of recommendations offer doctors conflicting advice, the researchers said. For now, they recommend that physicians and patients ‘engage in shared decision making around the potential benefits, harms, and patient preferences for treatment…'”
Dr. Suzanne Steinbaum, a preventive cardiologist at Lenox Hill Hospital in New York City, added:16
” … [M]edication should be the last resort and a true behavioral and healthy lifestyle program should be implemented… Regardless of the guidelines, we need to not have this younger generation rely on medication, but instill in them what healthy food choices, exercise, and smoking cessation means before simply giving them a pill. In the short term, it may reduce their cholesterol numbers, but ultimately with obesity and hypertension, their risk of heart disease will continue to escalate.”
New Class of Cholesterol-Lowering Drugs Approved… and They May Have Even More Side Effects Than Statins
The US Food and Drug Administration (FDA) approved the drug alirocumab (brand name Praluent) in July 2015.17 The European Commission (EC) also granted marketing authorization for evolocumab18 (brand name Repatha) for use in European patients. These medications belong to a new class of drugs called PCSK9 inhibitors, which increase your liver’s ability to soak up and remove low-density lipoprotein (LDL) from your blood by trapping it inside the cell.
The drugs are being touted as an alternative to statins for those in whom the treatment isn’t effective or who are unable to take them due to side effects… but results from a 78-week long study published in the New England Journal of Medicine show that Praluent causes higher incidence of many of the same side effects as statins:19,20
- 1.2 percent of patients who received both a statin and bi-weekly injections of Praluent experienced neurocognitive problems, such as memory impairment or confusion, compared to 0.5 percent of those taking a statin only
- 5.4 percent of those receiving statin plus Praluent suffered myalgia (muscle pain) compared to 2.9 percent of the statin only group
- 2.9 percent of the statin/Praluent group experienced eye problems, compared to 1.9 percent of the statin only group
Price may keep demand for PCSK9 inhibitors low, at least initially. The drug, which is administered as an injection, has a wholesale price tag of $1,200 per month, or $14,400 per year. For comparison, brand name statin drugs typically cost $500 to 700 per year and less than $50 a year for generics. Research firm GlobalData predicts Praluent has “extraordinary blockbuster potential” with the capability of generating $17.5 billion in sales by 2023 – but please use caution before considering this to be a “safer” or “more effective” alternative to statins…
Please Assess Your Real Risk for Heart Disease Before Resorting to Statins
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. And rather than relying on total cholesterol as your guide, 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 to 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 Without Drugs
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. In a nutshell, preventing cardiovascular disease involves reducing chronic inflammation in your body while optimizing your insulin level. Proper diet, exercise, sun exposure, and grounding to the earth are cornerstones of an anti-inflammatory lifestyle. For more details on how to naturally reduce your risk of heart disease, please review the following 10 heart-healthy strategies:
Eat REAL FOOD. Replace processed foods (which are loaded with refined sugar and carbs, processed fructose, and trans fat — all of which promote heart disease) with whole, unprocessed or minimally processed foods, ideally organic, and/or locally grown. Avoid meats and other animal products such as dairy and eggs sourced from animals raised in confined animal feeding operations (CAFOs). Instead, opt for grass-fed, pastured varieties, raised according to organic standards. Eliminate no-fat and low-fat foods, and increase consumption of healthy fats. Much of the population suffers with insulin resistance and would benefit from consuming 50 to 85 percent of their daily calories from healthy saturated fats, such as avocados, butter made from raw grass-fed organic milk, raw dairy, organic pastured egg yolks, coconuts and coconut oil, unheated organic nut oils, raw nuts, and grass-fed meats. No- or low-fat foods are usually processed foods that are high in sugar, which raises your small, dense LDL particles.
Balancing your omega-3 to omega-6 ratio is also key for heart health, as these fatty acids help build the cells in your arteries that make the prostacyclin that keeps your blood flowing smoothly. Omega-3 deficiency can cause or contribute to very serious health problems, both mental and physical, and may be a significant underlying factor of up to 96,000 premature deaths each year. Research suggests that as little as 500 mg of omega-3-rich krill per day may improve your total cholesterol and triglycerides, and will likely increase your HDL cholesterol.
You also need the appropriate ratios of calcium, magnesium, sodium, and potassium, and all of these are generally abundant in a whole food diet. To get more fresh vegetables into your diet, consider juicing. Optimize your vitamin D level. Some researchers, like Dr. Stephanie Seneff, believe optimizing your vitamin D level through regular sun exposure, opposed to taking an oral supplement, may be key to optimizing your heart health. If you do opt for a supplement, you also increase your need for vitamin K2. Optimize your gut health. Regularly eating fermented foods, such as fermented vegetables, will help reseed your gut with beneficial bacteria that may play an important role in preventing heart disease and countless other health problems. Quit smoking and reduce your alcohol consumption. Exercise regularly. Exercise is actually one of the safest, most effective ways to prevent and treat heart disease. In 2013, researchers at Harvard and Stanford reviewed 305 randomized controlled trials, concluding there were “no statistically detectable differences” between physical activity and medications for heart disease. High-intensity interval training, which requires but a fraction of the time compared to conventional cardio, has been shown to be especially effective. Pay attention to your oral health. There’s convincing evidence linking the state of your teeth and gums to a variety of health issues, including heart disease. In one 2010 study those with the worst oral hygiene increased their risk of developing heart disease by 70 percent compared to those who brush their teeth twice a day.21 Avoid statins, as the side effects of these drugs are numerous, while the benefits are debatable. If you are taking statins for any reason it is imperative to take coenzyme Q10, and I believe the best form is the reduced and called ubiquinol
Source: Dr. Mercola Blog