Statins Part I

Trying to stay healthy can seem like a full-time job sometimes. Especially during a pandemic. But I’m here to make that goal a little easier. Welcome to the Nutrition Facts podcast, I’m your host Dr. Michael Greger.

Did you know that the cholesterol-lowering drug Lipitor has become the best-selling drug of all time. That’s a lot of Lipitor. Today, we take a close look at how to calculate your own personal heart disease risk –and whether or not you should take a statin yourself.

The muscle-related side effects from cholesterol-lowering statin drugs “are often severe enough [to make] patients stop taking [them]. Of course, these side effects could be coincidental or psychosomatic and nothing to do with the drug,” given that many clinical trials show such side effects are rare. Of course, “[it’s] also possible that [those] clinical trials, [funded by the drug companies themselves,] under-[reported] the side effects.” The bottom line is that there’s an urgent need to establish the true incidence of statin side effects.

“What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?” Even in Big Pharma-funded trials that found “only a small minority of symptoms” to be attributable to statins, researchers found that those taking statins were significantly more likely to develop type 2 diabetes than those randomized to placebo sugar pills. Why? We’re still not exactly sure, but statins may have the double-whammy effect of impairing insulin secretion from the pancreas, as well as diminishing insulin’s effectiveness by increasing insulin resistance.

Even short-term statin use may approximately “double the odds of developing diabetes and diabetic complications.” And if that’s not bad enough, “this increased risk persist[s] for [years even] after [the] statin[s were] stopped.”

Now, “in view of the overwhelming benefit of statins in the reduction of cardiovascular events,” the #1 killer of men and women, any increase in risk of diabetes, only our 7^th leading cause of death, would be “outweighed by the cardiovascular benefits,” right? That’s a false dichotomy. We don’t have to choose between heart disease and diabetes. We can treat the cause of both with the same diet and lifestyle changes. The diet that can not only stop but reverse heart disease is the same one that can also reverse type 2 diabetes.

But what if, for whatever reason, you refuse to change your diet and lifestyle? In that case, what are the risks and benefits of starting statins? Don’t expect to get the full scoop from your doctor, as most seemed clueless about the causal link with diabetes; so, only a small fraction even bring it up with their patients.

 “Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits [are said to] greatly outweigh the risks.” But that’s for you to decide. Before we quantify exactly what the risks and benefits are, what exactly are the current guideline recommendations?

How should you decide if a statin is right for you? “If you have a history of heart disease or stroke, taking a statin medication is recommended”––period, full stop, no discussion needed. “If you do not yet have any known cardiovascular disease,” then the decision should be based on calculating your own personal risk, which you can easily do online if you know your cholesterol and blood pressure numbers with the American College of Cardiology risk estimator (tools.acc.org/ASCVD-Risk-Estimator), the Framingham risk profiler (reference.medscape.com/calculator/framingham-cardiovascular-disease-risk), or the Reynolds Risk Score (www.reynoldsriskscore.org).

My favorite is the ACC one, since it not only gives your current 10-year risk but also your lifetime risk. So, what do you do with that number? Well, under the current guidelines, if your 10-year risk is under 5 percent, then unless there are extenuating circumstances, you should just stick to diet, exercise, and smoking cessation to bring down your numbers. In contrast, if your 10-year risk hits 20 percent, then the recommendation is for you to add a statin drug on top of making lifestyle modifications. Under 7.5 percent, unless there are risk-enhancing factors, the tendency is to just stick with lifestyle changes, and over 7.5 percent to move towards adding drugs. Here’s a list of risk-enhancing factors that your doctor should take into account when helping you make the decision: a bad family history, really high LDL, metabolic syndrome, chronic kidney or inflammatory conditions, persistently high triglycerides, or C-reactive protein, or LP(a).

If you’re still not sure, these guidelines suggest you consider getting a coronary artery calcium score, but even though the radiation exposure from that test is relatively low these days, the U.S. Preventive Services Task Force has explicitly concluded that the current evidence is insufficient to conclude that the benefits outweigh the harms.

In our next story, the dirty little secret of drugs for lifestyle diseases? If patients knew the truth of how little these drugs actually worked, almost no one would agree to take them.

Drug companies go out of their way, for example in direct-to-consumer ads, to “present…drugs as [the] preferred solution to cholesterol management while downplaying lifestyle change.” You see this echoed in the medical literature. “Despite decades of exhortation for improvement,” this editorial in the Journal of the American Medical Association read, “the high prevalence of poor lifestyle behaviors. . .persists, with [heart attacks] and stroke[s] remaining the leading causes of death in the United States.” Clearly, we need to put more people on drugs. A reply was published in the British Medical Journal. “Once again, doctors are implored to ‘get real’—stop hoping that efforts to help their patients and communities adopt healthy lifestyle habits will succeed, and start prescribing more statins.” Don’t you see how “this is a self-fulfilling prophecy.” I should “note that the author of [the pro-statin editorial] disclosed funding from 11 different drug companies,” which make billions of dollars off cholesterol-lowering drugs.

Every time the cholesterol guidelines expand the number of people eligible for statins, they’re decried as a “big kiss to Big Pharma,” understandably since the majority of guideline panel members may have financial conflicts of interest. But these days, all the major statins are off-patent; so, there are inexpensive generic versions. For example, the safest, most effective statin is generic Lipitor, sold as atorvastatin for as little as a few bucks a month; so, these days, the cholesterol guidelines are not necessarily part of some industry plot.

It’s the American way of life that’s the problem, not the guidelines. The reason so many people are candidates for cholesterol and blood pressure-lowering medications is because people are taking such terrible care of themselves. The bottom line is that “individuals must take more responsibility for their own health behaviors.” But if you are unwilling or unable to improve your diet and make lifestyle changes to bring down that risk, if your 10-year risk of having a heart attack is 7.5 percent or more and gonna stay that way, then the benefits of taking a statin drug likely outweigh the risk. But that’s really for you to decide. It’s your body, your choice.

“Whether or not the overall [balance of benefit and harm] justifies the use of a medication for an individual patient cannot be determined by a guidelines committee, a health care system, or even [your] physician. Instead, it is the individual patient who has a fundamental right to decide whether or not taking a drug is worthwhile.” This was recognized by some of medicine’s luminaries, but only recently “has the medical profession [shifted] from a paternalistic ‘doctor knows best’ stance towards one explicitly endorsing patient-centered, evidence-based, shared decision-making.”

One of the problems with communicating statin evidence to support this shared decision-making is that most doctors have a poor understanding of concepts of risk, probability, and statistics. But that understanding is critical for preventive medicine. When doctors offer a cholesterol-lowering drug, they’re doing something quite different from treating a patient who is sick. They’re almost like “life insurance salespeople, peddling deferred benefits in exchange for a[n]. . .ongoing cost. In this new kind of medicine, not understanding risk is the equivalent of not knowing about [basic anatomy].” So, let’s dive in and see exactly what’s at stake.

When drug companies say a statin reduces the risk of a heart attack by 36 percent, that’s what’s called the relative risk. You can see how they came up with that. In a large clinical study, 3 percent of patients not taking the statin drug had a heart attack within a certain amount of time, compared to 2 percent taking the drug. So, the drug dropped heart attack risk from about 3 percent to 2 percent; that’s about a one-third drop, hence the 36 percent reduced relative risk statistic.

But another way to look at 3 percent to 2 percent is that the absolute risk only dropped 1 percent. So, in effect, “your chance of avoiding a…heart attack [over] the next [few] years is about 97 percent without treatment, but you can increase it to about 98 percent by taking [a statin] every day.” Another way to say that is that you’d have to treat 100 people with the drug to prevent a single heart attack. That statistic may shock a lot of people.

If you ask patients what they were led to believe, they don’t think the chance of avoiding a heart attack within a few years on statins is 1 in a 100, but 1 in 2. “On average it was believed that most patients…would [be able to avert] a heart attack,” not just 1 percent of patients. And “this disparity between [the] actual [benefits] and expected [benefits] could be viewed as a [doctor’s] dilemma. On the one hand, it is not ethically acceptable for care givers to deliberately” mislead people into thinking a drug works better than it really does. But on the other hand, how else are we gonna get people to take their pills?

If you ask people, they want an absolute risk reduction of at least about 30 percent to take a cholesterol-lowering drug every day, whereas the actual absolute risk reduction is really only about 1 percent. So, the dirty little secret is if patients knew the truth—how little these drugs actually worked—almost no one would agree to take them. So, either doctors are just not educating their patients, or they are actively misinforming them.

Given that the majority of patients expect a much larger benefit than they’d actually be getting, “there is a tension between the patient’s right to know…and the likely reduction in [willingness to take the drugs] if they [discovered the truth].” This sounds terribly paternalistic, but hundreds of thousands of lives may be at stake.

If patients were fully informed, people would die. About 20 million Americans are on statins. Even if they saved 1 in 100, that could mean hundreds of thousands of lives lost if everyone stopped taking their statins. “It’s ironic that informing patients about statins would increase the very outcomes they were designed to prevent.”

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