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Are statins overprescribed? Currently many people without heart disease and at low risk of heart disease are taking them as a preventive, what is known as "primary prevention". Over the years, changes in medical guidelines have resulted in more and more lower risk older healthy people being prescribed statins. But there has been controversy over this: Are the statins really preventing heart disease and deaths in these low risk people? Also, do the benefits outweigh the harms (because all medications have side-effects, some more serious than others)? Finally, are the extra financial costs worth it?

A recent study published in the prestigious British Medical Journal (BMJ) suggests that statins may be overprescribed in many such lower risk cases.  But please, keep in mind that for people with heart disease, statins are uncontroversial, where there are clear benefits. The controversy is regarding statins for low risk people without heart disease.

For example, the study researchers point out that studies find that statin use can be associated with an increased risk of diabetes, various muscle problems, and hemorrhagic stroke, as well as some  milder side-effects. Yet, looking at just one country (Ireland), with the latest medical guidelines it would take about 400 lowest risk healthy people taking statins to prevent one major cardiovascular event. And the statins would be taken for years. Is it worth it? Also, the studies being published are those favorable to the pharmaceutical industry, while under reporting harms.

From Medical Xpress: For most healthy people, benefits of statins 'may be marginal at best'   ...continue reading "Are Statins Overprescribed?"

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It turns out that we also have microbes called archaea living in and on our bodies. They are part of our microbiome (community of microbes living in and on us, which also includes bacteria, viruses, and fungi). Archaea constitute a domain or kingdom of single-celled microorganisms. These microbes are prokaryotes, meaning that they have no cell nucleus or any other membrane-bound organelles in their cells. Archaeal cells have unique properties that separate them from bacteria and eukaryotes. Archaea were initially classified as bacteria and thought to only exist in extreme environments (such as hot springs and salt lakes), and given the name archaebacteria, but this classification is now outdated. We now know that archaea live in less extreme places, including oceans, marshlands, animals, and humans.

So little is known about archaea that not even medical schools discuss this topic. This may be due to the fact that we currently don't know of any archaea that are human pathogens (that is, that cause illness) or parasitic. They are generally viewed as mutuals (the relationship is beneficial to both organisms) or commensals (they benefit, but don't help or harm the other organism). Humans appear to have low levels of archaea, and so far they have  been found in the human gut (part of digestion and metabolism), on the skin, and in subgingival dental plaque (and perhaps involved with periodontal disease). But studies rarely look for them. We don't know the importance or roles that they play in our bodies (but there are suspicions), but it turns out that drugs such as statins and the antibiotic metronidazole  are eliminating them.

Note that methanogens are archaea that excrete or produce methane as a metabolic byproduct in anoxic (no oxygen) conditions such as the gut. They help digest our food. The species Methanobrevibacter smithii  has been shown to be present in up to 95.7% of humans studied, and found to be the most abundant methanogen in the human gut, comprising up to as much as 10% of all anaerobes found in a healthy individual's colon. Anaerobes are organisms that require oxygen-free conditions to live. Some of the June 2015 article (by M. N. Lurie-Weinberger and U. Goph) excerpts from PLOS:

Archaea in and on the Human Body: Health Implications and Future Directions

Although they are abundant and even dominant members of animal microbiomes (microbiotas), from sponges and termites to mice and cattle, archaea in our own microbiomes have received much less attention than their bacterial counterparts. The fact that human-associated archaea have been relatively little-studied may be at least partially attributed to the lack of any established archaeal human pathogens. Clinically oriented microbiology courses often do not mention archaea at all, and most medical school and biology students are only aware of archaea as exotic extremophiles that have strange and eukaryotic-like molecular machinery. Since archaea have been known to be associated with the human gut for several decades, one would think that human microbiome studies may unravel new facets of archaea–human interactions...  ...continue reading "We Have Archaea In and On Our Bodies"

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Controversy exists over whether healthy people should take statins because of possible side effects. This is another study finding a very elevated risk of new onset diabetes, high risk of diabetes complications, and obesity in statin users. This finding was also significant because the statins were given to healthy people (with no heart disease, diabetes, or severe chronic disease). Risks of diabetes, diabetes complications, and obesity were dose related. Statin users were also paired with similar non-statin users and then followed - thus the only differences between the 2 groups was whether they used statins. The researchers themselves write that when considering risks of statins, people should try for lifestyle changes (lose weight, eat healthy, exercise, stop smoking) rather than just rely on popping a pill. From Medical Xpress:

Strong statin-diabetes link seen in large study of Tricare patients

In a database study of nearly 26,000 beneficiaries of Tricare, the military health system, those taking statin drugs to control their cholesterol were 87 percent more likely to develop diabetes.

The study, reported online April 28, 2015, in the Journal of General Internal Medicine, confirms past findings on the link between the widely prescribed drugs and diabetes risk. But it is among the first to show the connection in a relatively healthy group of people. The study included only people who at baseline were free of heart disease, diabetes, and other severe chronic disease."In our study, statin use was associated with a significantly higher risk of new-onset diabetes, even in a very healthy population," says lead author Dr. Ishak Mansi. 

In the study, statin use was also associated with a "very high risk of diabetes complications," says Mansi. "This was never shown before." Among 3,351 pairs of similar patients—part of the overall study group—those patients on statins were 250 percent more likely than their non-statin-using counterparts to develop diabetes with complications. Statin users were also 14 percent more likely to become overweight or obese after being on the drugs....The study also found that the higher the dose of any of the statins, the greater the risk of diabetes, diabetes complications, and obesity.

A key strength of Mansi's study was the use of a research method known as propensity score matching. Out of the total study population, the researchers chose 3,351 statin users and paired them with non-users who were very similar, at baseline, based on array of 42 health and demographic factors. The only substantial difference, from a research standpoint, was the use of statins. This helped the researchers isolate the effects of the drugs.

On a wider scale, looking at the overall comparison between the study's roughly 22,000 nonusers and 4,000 users, and statistically adjusting for certain factors, the researchers found a similar outcome: Users of statins were more than twice as likely to develop diabetes.The researchers examined patient records for the period between October 2003 and March 2012. About three-quarters of the statin prescriptions in Mansi's data were for simvastatin, sold as Zocor.

"I myself am a firm believer that these medications are very valuable for patients when there are clear and strict indications for them," he says. "But knowing the risks may motivate a patient to quit smoking, rather than swallow a tablet, or to lose weight and exercise. Ideally, it is better to make those lifestyle changes and avoid taking statins if possible."

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This article raises serious questions about the recently published American College of Cardiology and American Heart Association calculators to predict future cardiovascular events (heart attack, strike, etc) which then give recommendations for who needs to take daily statins while they are still healthy. This calculator (ACC/AHA risk calculator) has sparked much debate because many experts believe it overestimates risk. Now a study that looked at untreated people (MESA) showed that the calculator (as well as 3 other calculators) seriously overpredict the chance of a future cardiovascular event. In other words, many, many healthy people told they "may" have a chance of an event in the future are actually not at risk and so statins would not help them, but may harm them. Remember, all medicines have side-effects. Written by cardiac electrophysiologist Dr. John Mandrola (who has his own blog-site www,drjohnm.org) . From Medscape:

Statins in Primary Prevention: Welcome to the Gray Zone

A new study published in the Annals of Internal Medicine confirmed something that ought to be obvious: predicting the future is hard—especially when it comes to cardiovascular events.

We know cardiovascular disease is the number-one killer of humans; we know its first manifestation is often heart attack, stroke, or death; and we know all medical therapy comes with trade-offs. Medical treatment of healthy people in the name of preventing something that may or may not happen in the future is dicey. Think do no harm. That is where risk prediction comes in. You have to know the odds of something (or nothing) happening without treatment. The gamble of statins and aspirin, for instance, looks most favorable in patients who are most likely to have an event.

 But where to draw that line, at what future risk is it worth taking a chemical, is the issue at hand. The extreme cases are easy. Most everyone agrees that statins and aspirin provide enough benefit in patients who have suffered a cardiovascular event. For secondary prevention, future risk is high, so benefits outweigh harms. It's the opposite in very low-risk patients. The middle ground is not so easy.

Here is where we have to consider the tools—calculators—to predict future risk. We know certain conditions, such as age, gender, blood pressure, diabetes, smoking, biomarkers, family history, and coronary calcium, contribute to future risk. Numerous expert panels, including the American College of Cardiology and American Heart Association, have compiled different calculators to predict the future. The ACC/AHA risk calculator for atherosclerotic CVD (ASCVD) has sparked debate because many experts believe it overestimates risk.

Dr Andrew DeFillippis (University of Louisville, KY) and a team of Multi-Ethnic Study of Atherosclerosis (MESA) coinvestigators used this community-based, sex-balanced, multiethnic cohort to compare the calibration and discrimination of the new ASCVD risk score with alternative risk scores.They compared the observed and expected events for the ASCVD score with three Framingham-based scores and the Reynolds risk score in 4227 MESA subjects aged 50 to 74 years over a 10-year follow-up. Using this real-world population, they found four of the five risk scores overestimated risk. Calibration was worse in men: overestimates ranged from 37% to 154%. In women, three of four scores overestimated risk by 46% to 67%, and the Reynolds Risk score underestimated risk by 21%. 

It's worth saying this another way: when the ACC/AHA ASCVD score predicted event rates of 7.5 to 10%—a range deemed above the statin-benefit cutoff—the actual events were just 3%.

Speaking by phone (we live in the same city), lead author Dr DeFillippis explained to me the important business of looking only at untreated patients. He described their sensitivity analysis, which excluded all patients who received aspirin or any lipid-lowering or antihypertensive drug. To lessen the chance of bias, they analyzed this drug-free group of 790 patients separately and found the same overprediction.The authors concluded that if these findings are validated, overestimation of ASCVD risk may have substantial implications for individual patients and the healthcare system.

On that modern theme, Dr DeFillippis made an interesting point to me about the overall best-performing Reynolds Risk score. He noted the Reynolds score uses genetics (family history) and CRP (inflammation) levels to predict the future. Bookmark that for the future—genetics and inflammation, that is.

These findings have major implications. Drugs are not free. Aspirin and statins come with side effects and dollar costs. The patient who takes these drugs in hopes of preventing future events makes the gamble that the costs are worth the benefit. Policy makers who recommend these drugs expose millions of people to a therapy that turns on delicate balance between future benefit and harm.

The final point to make is that the use of statins and other drugs for the prevention of future events is not a doctor's or professional society's decision. The human being who swallows a drug must ultimately decide whether the gamble is favorable.

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I am starting to read more and more negative comments from physicians and researchers about the big pharma and medical society recommendations for treating currently healthy people with statins in the hope it may prevent a cardiovascular event in the future. Many point out that statin health benefits are overstated while negatives and side-effects have been minimized. Many are pointing out that instead of statins, there should be recommendations for lifestyle changes, such as reducing weight, increasing exercise, not smoking, reducing stress, and cutting back on alcohol consumption. After all, these lifestyle changes ONLY have positive effects, and zero negative side effects. From Medical Xpress:

Safety and life-saving efficacy of statins have been exaggerated, says USF scientist

Hailed as miracle drugs when they hit the market two decades ago, statins, the cholesterol-lowering drugs prescribed to prevent heart attacks, are not as effective nor as safe as we have been led to believe, say Dr. David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr. Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular disease.

According to Diamond and Ravnskov, statins produce a dramatic reduction in cholesterol levels, but they have "failed to substantially improve cardiovascular outcomes." They further state that the many studies touting the efficacy of statins have not only neglected to account for the numerous serious adverse side effects of the drugs, but supporters of statins have used what the authors refer to as "statistical deception" to make inflated claims about their effectiveness.

Their paper is an analysis of the data in the statin trials which led them to conclude that "statin advocates have used statistical deception to create the illusion that statins are 'wonder drugs,' when the reality is that their modest benefits are more than offset by their adverse effects."

The paper also describes how the basis of the deception is in how authors of the statin studies present the rate of beneficial and adverse effects. The effect of the drugs on the population is called the 'absolute risk,' which has shown that statins benefit only about 1% of the population. This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don't present the 1% effect to the public. Instead they transform the 1% effect using another statistic, called the "relative risk," which creates the appearance that statins benefit 30-50% of the population. The exaggeration of beneficial effects of statin treatment was illustrated in their analysis of a subset of statin studies, including the Jupiter Trial (Crestor), the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), and the British Heart Protection Study.

"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," said Ravnskov and Diamond.... 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 adverse effects suffered by people taking statins are more common than reported in the media and at medical conferences" explains Diamond and Ravnskov. According to the authors, "Increased rates of cancer, cataracts, diabetes, cognitive impairments and musculoskeletal disorders more than offset the modest cardiovascular benefits of statin treatment."

The authors emphasized that low cholesterol levels related to statin use have frequently been associated with an increased risk of cancer. They also noted that most statin trials are terminated within two to five years, a period too short to see most cancers develop. Nevertheless, studies have shown a greater incidence of cancer in people who take statins, and one long-term study demonstrated a dramatic increase in the incidence of breast cancer among women who had used statins for more than 10 years.

They emphasized that the public needs to be wary of conflicts of interest in the medical community and pharmaceutical industry when it comes to touting the benefits of statins and skewing the data in such a way as to make the drugs seem more effective at lowering cardiovascular disease and heart attack risks than they may actually be.

The authors advocate other health beneficial strategies that are known to reduce cardiovascular risk, such as cessation of smoking, weight control, exercise and stress reduction. They also emphasized the great value of a low carbohydrate diet for normalizing all of the biomarkers of cardiovascular risk, with excellent outcomes, especially for people with type 2 diabetes.

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According to a new report, exercise can be as effective as many frequently prescribed drugs in treating some of the leading causes of death. This is a major finding! From the Dec.11, 2013 NY Times:

Exercise as Potent Medicine

For the study, which was published in October in BMJ, researchers compared how well various drugs and exercise succeed in reducing deaths among people who have been diagnosed with several common and serious conditions, including heart disease and diabetes.

They ended up with data covering 305 past experiments that, collectively, involved almost 340,000 participants, which is an impressive total. But most of the volunteers had received drugs. Only 57 of the experiments, involving 14,716 volunteers, had examined the impact of exercise as a treatment.The researchers compared mortality risks for people following any of the treatment options.

The results consistently showed that drugs and exercise produced almost exactly the same results. People with heart disease, for instance, who exercised but did not use commonly prescribed medications, including statins, angiotensin-converting-enzyme inhibitors or antiplatelet drugs, had the same risk of dying from — or surviving — heart disease as patients taking those drugs. Similarly, people with diabetes who exercised had the same relative risk of dying from the condition as those taking the most commonly prescribed drugs.

On the other hand, people who once had suffered a stroke had significantly less risk of dying from that condition if they exercised than if they used medications — although the study authors note that stroke patients who can exercise may have been unusually healthy to start with.

Only in chronic heart failure were drugs noticeably more effective than exercise. Diuretics staved off mortality better than did exercise.

Over all, Dr. Ioannidis said, “our results suggest that exercise can be quite potent” in treating heart disease and the other conditions, equaling the lifesaving benefits available from most of the commonly prescribed drugs, including statins.