Let me ‘cut to the chase.’ The British Medical Journal published a study on January 22, 2015 presenting an argument that statins save fewer lives than simple lifestyle changes like exercising and eating sensibly. Yes, I know that many people don’t want to be bothered by changing their eating, smoking or exercising habits. It’s no surprise that popping a daily pill (likely covered by health insurance) is the easy way out. They can continue to eat pizza, double-double cheeseburgers, and cheesecake, while sitting on the sofa, and still lower their risk of heart disease by a simple daily pill swallowing – maybe. I hope it works that way for all those counting on it.

Sure there are problems. Our society promotes cheap unhealthy foods, low alcohol prices and the use of cars instead of walking or cycling. Even though there are relatively cheap statin options, it costs America $19 to $22 billion each year. We all pay the tab – just because it’s a low cost to the patient, doesn’t mean that all of us are not paying for it through our taxes. Certainly, it has been shown that taking statins can lower the risk of heart attack, stroke and death. The researchers at the University of Liverpool found, however, that more effort should be put into population-wide programs that improve overall health.

Having said that statins lower the risk, on average, of heart attack, stroke and death, I generally have an additional concern – what else can happen when we add even more pharmaceuticals to our lives than we are already taking? One recent personal experience with pharmaceuticals may help to illustrate my concern. I took Celebrex for rheumatoid arthritis for about a year and a half. It helped the joint pain, but subtly, without warning, and without much information that it happened to some people, I was suffering from increasingly very painful feet – peripheral neuropathy. It took months to begin to suspect the Celebrex. I read articles on this little-known effect of Celebrex and told my doctor I wanted to try going off the drug. He agreed. Another doctor asked me to share what I found from reading and my personal experiment. (I gravitate toward open-minded and non-dogmatic physicians). Within only a couple of days the neuropathy began improving; after months of increasingly greater neuropathy. Certainly for most of the population, Celebrex is a trouble-free medication. But if you happen to have numb, tingling and painful toes/feet, it matters. The peripheral neuropathy is completely gone now, so that’s great for me. Sometimes it is irreversible though; I’m very blessed. We always have to remember that pharmaceuticals do come with risks. These risks are different for different people, and for different mixes of other pharmaceuticals people are also taking. Genetic typing is being used increasingly in studies to find out how different genotypes react to drugs, but even then not all individual differences or interactions with so many other pills and substances people take can be teased out. Research that compares group averages can only make inferences about averages (means), not about individual cases.

As of March of 2014 about 25 million Americans were taking statins. About half of the U.S. population between 40 and 75 years old qualify for statin therapy under the new guidelines published in November 2013. When the new guidelines were changed the medical professionals responsible for the guidelines decided to lower the risk criteria for eligibility to 7.5 percent or higher for heart attack or stroke within the next 10 years; that puts additional pills into the mouths of an estimated 33 million Americans who currently are without cardiovascular disease. Really? A 7.5% risk over the next 10 years. Increasing the numbers of people taking statins by the millions, medicinizes many healthy people. This has generated controversy. Is it all about selling statins? The dose has also been increased; so the pharmaceutical companies win that way too. That spells a boon for Big Pharma and increased risk of side effects for us.

One complex statistical study published in The Lancet tried to compare the well-known risk of increased incidence of type-2 diabetes following statin therapy with the benefits of reduced cardiovascular events and mortality. Their argument is that if we reduce the incidence of cardiovascular events but increase cases of diabetes, is it worth it?  Over five years, their statistics say there was a greater reduction of the cardio events than the appearance of new diabetes cases, as if you could compare the seriousness of one with another. If you have a serious stroke or die of a heart attack, it seems easy to say that was worth getting diabetes over that 5-year period.  But the study, funded by Astra-Zenica, stopped there. It is well known that diabetes develops over time periods greater than 5 years, and can result in later cardiovascular events. The Lancet publishes well-done studies, but it always makes me a little nervous when I just happen to notice that AstraZeneca (maker of the statin Crestor) funded the study. They can keep their hands off the study design and writing, but they can refuse to fund studies that have a design that risks opening new embarrassing questions. This one had a chance to show that statins helped more than they hurt, and it did. I guess that I can’t get past the concept of conflict of interest – just sayin!’ Like diabetes, and like my peripheral neuropathy, side effects may develop slowly over long times.

It’s not just the dilemma with the increased incidence of type-2 diabetes, but there are many other side effects, including: muscle pain, joint pain, memory loss (cognitive issues), fatigue, elevated blood sugar, cataract risk, liver and other problems. Most of the type-2 diabetes is reversible, but the small increased risk of 0.5-1.1% of type-2 diabetes, for example, that is not reversible should not be dismissed lightly. That’s approximately 264,000 new persons with type-2 diabetes. Ouch! Of course, Big Pharma has an answer:  we can take care of that with Metformin or insulin, or a number of newer diabetes drugs. As I mentioned above, I was so grateful that my peripheral neuropathy was reversible, but for some, it is not. It’s a little frightening to end up with a medical problem that you did not have prior to taking a medication.

I really enjoyed reading an editorial Maximizing the benefits and minimizing the harms of statins. (Click on PDF when you get to the site.) It’s really written for medical doctors, but if you want to understand NNT (numbers needed to treat) and how it can taint a study, you may enjoy it too. It may help clear up confusing study design, also.  In addition, they address RCT (randomized controlled trial, the gold standard for clinical trials.) The authors’ contention is that RCT patients often do not represent the true population; RCTs may therefore seriously underestimate adverse effects such as muscle pain or cognitive impairment and fail to detect drug interactions. This paper reminds us to not forget that a patient with low risk may get the same benefit of myocardial infarction risk reduction by eating an apple a day as taking statins. Don’t forget my old article An Apple a Day.  In another study led by Estruch, published in the NEJM, it was found that a 30 percent risk reduction in high risk groups could be had by consuming a handful of nuts or four tablespoons of extra virgin olive oil daily (see my old article called; Mediterranean-Style Eating is Joyful Delicious Eating. Maybe we should seriously reconsider lifestyle changes.

Malhotra et al said, “Indeed 80 percent of cardiovascular disease is attributable to lifestyle factors including an unhealthy diet, smoking and lack of physical activity.  For those individuals at low risk it is clear that the benefits of statins are modest at best.” And Guzman-Castillo, who led the Liverpool study cited above, said; “Severely limited healthcare budgets are now forcing planning systems to consider how best to allocate future resources.  Our results strengthen the case for greater emphasis on preventive approaches, particularly population-based policies to reduce blood pressure and cholesterol. Such strategies might be more powerful, rapid, cost-effective and equitable than additional preventive medications.”

Can we not see that statins should possibly be reserved for those at the highest risk and most perverse refusal to eat well or exercise? Wouldn’t the others be served best by education in safely changing their lifestyle, without the risk of statins’ side effects? Think about it; for individuals with lower risk, lifestyle change may be far better than statins.