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Statin Denialism

Feature

Harriet Hall

Skeptical Inquirer Volume 41.3, May/June 2017

When Richard Dawkins was asked to justify his belief in the scientific method, he answered, “It works, bitches!”1 When the scientific evidence is compelling, one would have to be willfully perverse to reject it. But some people do; they reject findings that don’t fit with their ideology. We call them denialists. We have climate change denialists, HIV/AIDS denialists, vaccine denialists, evolution denialists, even germ theory denialists. And we have statin denialists.

Statins work, bitches! But the public perception has been skewed by alarmist misinformation from statin denialists.

A Hilarious Example of Statin 
Denialist Propaganda

Statin denialists rely on “alternative facts”; in other words: lies. The worst example of anti-statin misinformation I have ever seen is a YouTube interview with Dr. Leonard Coldwell. Not a word of what he says is true, and much of it is hilariously funny. Some of his statements are so obviously ridiculous that it’s hard to believe they wouldn’t leave even the most scientifically naive viewer rolling on the floor. Who is Leonard Coldwell? He has no medical or scientific credentials, yet he claims to be the world’s leading authority on cancer and to have treated over 35,000 cancer patients with a 92.3 percent cure rate. I think even Alice’s White Queen, having practiced believing as many as six impossible things before breakfast, would find that hard to swallow.

For your entertainment, I will provide the complete transcript of Coldwell’s deliciously absurd video2 along with my reality checks that are italicized and noted in brackets. To begin with, the interviewer says a number of statins have been pulled off the market.

[A little rudimentary fact-checking reveals that the number of statin-containing products removed from the market is three, and two of those were mixtures of statins with other drugs. The statins in those mixtures remain on the market, so the true number is one: Baycol, or cerivastatin, was voluntarily withdrawn from the market when post-marketing surveillance showed that it was five to ten times more likely than other statins to cause a serious complication, rhabdomyolysis.]

When the interviewer asks his opinion of statins, Coldwell says: “It’s mass murder. [Murder is premeditated killing. Does he really think doctors are deliberately trying to kill patients?] It always leads to hardening of the liver, [No, statins actually reduce the risk of cirrhosis of the liver.3] it cuts off at least twenty years of your life span. [Nonsense! It does just the opposite, particularly for patients at high risk of cardiovascular events.] Your brain is made from cholesterol. [Maybe if you’re a fathead! For the rest of us, our brain is made of a lot of other things in addition to cholesterol.] Statin is a cholesterol-lowering drug. So, if you want to have a brain that’s the size of a marble, keep on taking them. [Whaaat? No one has ever had a brain that’s the size of a marble for any reason; and the brains of patients on statins are the same size as the brains of patients not on statins.] You do not die of too much cholesterol, you die of not enough. [You don’t die of either; you die of heart attacks and strokes, and reducing high cholesterol levels reduces your risk of those events.] There is no such thing as too much cholesterol. [Yes, there most certainly is. People with familial hypercholesterolemia die prematurely.] In a burn unit, we use twenty to twenty-eight hard-boiled eggs a day, in a burn victim, [He just made that up. No burn unit does that, and if they tried it, the patients would surely rebel.] because we know only cholesterol builds healthy cells. [Only cholesterol? How silly! A lot of other components are required to build healthy cells.] Every cell in your system, 87 percent of the new cell, is built from cholesterol. [No, it isn’t! Lipids account for half the mass of cell membranes, and cholesterol makes up 20 percent of those lipids.4] Where does this cholesterol come from? They just made up the number of 250; they just made it up. [No, they didn’t! They measured cholesterol levels in large populations and found that people with higher levels of cholesterol were more likely to have heart attacks.] There’s no science, no nothing. They tested a couple of people living in a trailer park, from trash that they eat, [That’s insulting to people who live in trailer parks, and it’s demonstrably not true. Much of the original information about cholesterol and cardiovascular risk came from a large study that recruited a cross-section of people living in Framingham, Massachusetts, a prosperous town with no excess of trailer parks.] and they came up with the average is kind of like 250 of combined cholesterol. And that’s what everyone should have. [No one is recommending that everyone have 250 of combined cholesterol. Risk is determined not just by total cholesterol but by levels of “good” HDL cholesterol and “bad” LDL cholesterol, and of other lipid subfractions, as well as other risk factors such as smoking and diabetes.] It’s completely artificially made up. [No, it’s based on solid science.] I have patients who have a cholesterol of 600; they’re the healthiest people, never been sick.” [Never been sick yet. Patients with a cholesterol of 600 are at high risk of cardiovascular events and death, and it is irresponsible for a doctor not to treat such high levels.]

Incredible Silliness about Salt

“And you know where the myth comes from? People take table salt. Table salt is one-third glass, one-third sand, one-third salt. So now, the glass in the table salt is cutting the arteries. Now you’re bleeding to death internally. Now the cholesterol goes there and stops the bleeding. Keeps you alive, saves your life. The cholesterol is the bad guy because it narrows, of course, it clogs an open wound, that’s bleeding; of course it narrows for a short amount of time, the blood way. And then they say, oh yeah, because it’s now narrowed, it’s raising your blood pressure, and what’s raising your blood pressure is causing the narrowing. It’s the cholesterol, therefore, cholesterol is causing high blood pressure. Oh, very interesting.”

[This is by far the funniest part of the whole interview. Think about it. In the first place, the FDA tests salt and requires that all U.S. table salt be at least 97.5 percent pure sodium chloride. If table salt were one-third glass shards, wouldn’t you notice sharp particles in your salt? Wouldn’t it cut your tongue and mouth? Sprinkle some into your hand and see if anything feels sharp. If you swallow glass and sand, they might irritate the lining of the gastrointestinal tract; but then they would be eliminated in the feces. There is no way they could be absorbed into the blood stream and find their way to the coronary arteries.

This whole idea is a ridiculous urban myth that not even Mythbusters would take seriously enough to test; but anyone could easily test it in their own kitchen. Sand and glass are not soluble in water. If table salt were one-third sand and one-third glass, dissolving it in water would leave an insoluble residue comprising two-thirds of the original amount. The RationalWiki article on Leonard Coldwell says, “He has precious little understanding of medicine or human biology, and his understanding of basic science is virtually non-existent: any man who genuinely fails to understand the fact that glass and sand are not actually soluble in water is probably not best placed to offer health advice.”5]

Coldwell Continues Blathering

“So, the statin drugs are the most dangerous, useless drugs ever invented, [Doesn’t he know anything about the history of medicine? It would be trivially easy to identify drugs that were far more dangerous and totally useless.] and please remember your brain is built from cholesterol. 92–99 percent of the brain is built from cholesterol. [No, it isn’t! Our brain is 60 percent fat, with around 25 percent of that being cholesterol, mostly in the myelin that sheathes the neurons’ axons.6] Every statin drug starts shrinking the brain. [No statin drug shrinks the brain. In fact, statins may have a protective role in the development of dementia. A recent meta-analysis of observational studies showed they were associated with a significantly lower risk of Alzheimer’s disease.7]

And this is what people need to understand. Just have a couple of bananas on an empty stomach in the morning and you will see your liver get so much better really, really fast. It works so much better. Just help your body. [A non sequitur. There is no evidence that eating bananas can reverse liver disease, and how on Earth did he manage to segue from heart disease to liver disease?] You don’t need to cure it; you don’t need to fix it; just help it. It cures itself. Because my statement, there’s no healing force outside the human body, always comes true at the end of the day. There’s absolutely no healing force outside the human body. [No one claims statins “heal” or “cure” anything. They simply reduce the risk of cardiovascular events.] So, every time they tell you there’s a magic pill, [No one is suggesting statins are magic pills; they are drugs with risks and benefits, and the benefits have been determined to outweigh the risks.] and do you know why they always take the drugs off the market? When they become free or generic and they don’t need the big bucks.” [Several statins are now off-patent and available as generic drugs. Not one of those has ever been taken off the market.]

No one with a modicum of education in science and critical thinking would believe Coldwell’s claims. Even uneducated people with the tiniest bit of common sense ought to at least question the claim about salt being two-thirds sand and glass. And yet people do believe him and repeat his falsehoods.

Other Sources of Misinformation

Leonard Coldwell is far from the only one spreading “alternative facts” about statins. Joseph Mercola8 says “Cholesterol is NOT the cause of heart disease.” And “if you take statins, you MUST take CoQ10.” He claims that statins impair numerous biological functions, including all your sex hormones. He says ninety-nine out of 100 people do not need statins. He says that statins are teratogenic, that they cause birth defects if taken during pregnancy. The evidence says otherwise.9

Mike Adams, the Health Ranger, cherry-picks the literature and writes alarmist headlines about statin studies on the Natural News website. Typical examples: “Drug’s benefits were 100% fabricated,” “Statins are totally worthless,” “Statins cause debilitating muscle pain in up to 40%,” “Lowering cholesterol has NO EFFECT on risk of heart disease or death,” “Flu vaccines are useless to people taking statin drugs—and both cause brain damage.” When you consult the actual studies he refers to, you will find that his headlines misrepresent their findings. He even repeats the nonsense about sand and glass in table salt.10

And then there is the International Network of Cholesterol Skeptics (THINCS), a group that disputes the role of cholesterol in cardiovascular disease. They are led by Uffe Ravnskov, author of The Cholesterol Myths, and Malcolm Kendrick, author of The Great Cholesterol Con. They cherry-pick the scientific literature to find studies that support their theses, ignore the flaws in those studies, and ignore the vast body of literature that contradicts them. In The Skeptic’s Dictionary, Bob Carroll explains how they use distortions and deceptive techniques in their arguments.11


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What Is the Evidence for Statins?

Statins have been extensively studied; a PubMed clinical query brings up over 30,000 published articles. I couldn’t possibly read them all, but expert panels and review articles have done the heavy lifting and have identified the studies worth reading. The panels not only read all the pertinent studies, both pro and con, but they critically evaluated the methodology and the credibility of their findings. A 2016 review in the Lancet was particularly thorough. It found that the benefits of statins have been underestimated. The evidence couldn’t be clearer: they reduce the rate of heart attacks and strokes in at-risk patients by as much as 50 percent in some cases.12 Low-cost statins (about £2 for a month’s treatment) reduce LDL cholesterol by more than 50 percent. Large-scale evidence from randomized trials shows that for every 1 mmol/L reduction in LDL cholesterol with statin therapy, there is a proportional reduction of about 25 percent in the rate of major vascular events (coronary deaths, heart attacks, strokes, etc.) during each year that statins are used. Lowering LDL cholesterol by 2 mmol/L reduces risk by about 45 percent. Lowering LDL cholesterol by 2 mmol/L with statins for five years in 10,000 patients would prevent major vascular events in 1,000 patients at high risk and 500 patients at lower risk.

Statins may not work only by lowering cholesterol. Statins also have anti-inflammatory effects that probably contribute to the reduction in cardiovascular events. But the authors of the Lancet article felt there was sufficient evidence from various sources to establish a causal relationship between cholesterol and atherosclerosis. They noted that lower concentrations of cholesterol have been associated with higher death rates, particularly in the elderly (something the statin denialists love to point out), but they say those associations can be shown not to be causal.

Figure 1. Illustration of the Mayo Clinic visual decision aid available online.

The problem is that we only have population statistics. We can’t predict which individuals will benefit from statins, so we have to treat everyone at risk. That means that a lot of individuals who take statins will not benefit. One way to look at the data is to calculate the NNT, the number of patients needed to be treated for one patient to benefit. By one estimate, the NNT to prevent one heart attack in patients who already have heart disease is sixteen to twenty-three, to prevent a death, forty-eight. For patients who have risk factors but don’t yet have heart disease, the NNT is between seventy and 250.13 These are overall estimates for populations; the actual NNT will vary according to the individual’s personal risk factors. Visual decision aids14 are available online where you can input an individual’s cholesterol, blood pressure, and other risk numbers and get an easy-to-interpret diagram like the example from the Mayo Clinic in Figure 1.

Expert panels have repeatedly evaluated all the available evidence. In 2013, the American College of Cardiology and the American Heart Association jointly issued extensive treatment guidelines based on that evidence.15 The magnitude of the benefit is small, but it is greater for patients at higher risk. And if you are one of the patients who are saved from a heart attack, the benefit is pretty important. The guidelines are not prescriptions; they are intended to be used as general guidelines to facilitate interpretation of the evidence for the individual patient. Science can provide evidence about benefits and risks, but ultimately patients must choose whether to take the drugs and whether the benefits outweigh the risks for them, personally. People’s willingness to take risks varies, as does their attitude about insurance.

What about the Side Effects?

Any drug that has effects is likely to have side effects, and clinicians always weigh the benefits against the risks. What’s more, drug manufacturers have to demonstrate that the benefits outweigh the risks before the FDA ever approves a drug for marketing. That same review article in Lancet found that the adverse effects of statins have been overestimated.16 Devastating side effects have been reported, including cancer, dizziness, depression, anemia, acidosis, pancreatitis, cataracts, heart failure, hunger, nausea, sleep problems, memory loss, ringing in the ears, “a sense of detachment,”. . . the list goes on. But these are from anecdotal reports and uncontrolled observations.

When symptoms such as these have been evaluated in controlled studies, they have not been shown to occur more often with the drug than with placebo. The Lancet article concluded, “The only excesses of adverse events that have been reliably demonstrated to be caused by statin therapy are myopathy and diabetes mellitus, along with a probable excess of haemorrhagic stroke. These excesses are larger in certain circumstances, but the absolute risks remain small by comparison with the absolute benefits.” Treating 10,000 patients for five years might cause five cases of myopathy, fifty to 100 new cases of diabetes, and five to ten hemorrhagic strokes. The increase in hemorrhagic strokes is outweighed by the much greater decrease in ischemic strokes, and the clinical relevance of new diabetes diagnoses is minimal when weighed against the benefits of statin therapy. And a meta-analysis of subsequent studies found that the risk of diabetes was lower than in the study that first reported it.17

There are a lot of reports of muscle pain and weakness, but there is good evidence that most of them are not related to statin therapy. Out of 10,000 patients treated, only about ten to twenty will develop muscle pain and weakness, and only one of those will be diagnosed with myopathy requiring statin discontinuation. Only two to three cases of the serious complication rhabdomyolysis will be diagnosed for every 100,000 patients treated. The harmful effects of statins can usually be reversed by stopping the drug. If you don’t take statins and have a heart attack or stroke, those are not reversible.

Statin Denialism Harms Patients

Irresponsible media reports of statin side effects have frightened a lot of patients into discontinuing their treatment. Recently in the United Kingdom, following publication of exaggerated claims about statin side effects, more than 200,000 patients stopped their statins. By one estimate, this is likely to result in 2,000 to 6,000 cardiovascular events in the following decade that could have been prevented.18

Why Denialism?

Why do statin denialists rely on “alternative facts”? What motivates them to reject evidence that the majority of the medical and scientific community have reached a consensus on? I don’t think there’s a simple answer, but I suspect part of the problem is an anti-establishment ideology that automatically rejects anything that comes from Big Pharma or mainstream medicine, and sometimes even invents conspiracy theories. Another part is that so many people want to believe that if you just eat right, you won’t ever get sick, and that there must be natural lifestyle solutions to every health problem. There aren’t.

Other factors that can motivate denialism are religious ideology, self-interest (financial, political, economic), and the desire to protect oneself from unpleasant truths by denying reality. And of course, people who don’t understand how science works are more likely to reject it; they won’t accept the consensus of experts because they see it as nothing more than “opinion.”

Denialists are welcome to their poorly informed opinions, but they are not welcome to their “alternative facts.” Global warming is real, germs cause disease, HIV causes AIDS, evolution is an established fact, vaccines save lives. And statins, while they are not a panacea for everyone, have been clearly shown to do more good than harm for patients at risk.

Statins: They work, bitches!



Notes

  1. The full Dawkins quotation is “[Science] works! Planes fly. Cars drive. Computers compute. If you base medicine on science, you cure people. If you base the design of planes on science, they fly. If you base the design of rockets on science, they reach the moon. It works . . . bitches.” The saying “Science: It works, bitches” originally appeared in an xkcd cartoon and on a T-shirt, illustrated by a graph showing a perfect correlation between data from the COBE mission and Planck’s predictions for black body radiation.
  2. https://www.youtube.com/watch?v=9trx6opxmBI
  3. https://www.ncbi.nlm.nih.gov/pubmed/27166128
  4. http://www.nature.com/scitable/topicpage/cell-membranes-14052567
  5. http://rationalwiki.org/wiki/Leonard_Coldwell
  6. https://www.psychologytoday.com/blog/iage/201402/cholesterol-and-our-aging-brain
  7. http://atvb.ahajournals.org/content/24/5/806
  8. http://articles.mercola.com/sites/articles/archive/2010/07/20/the-truth-about-statin-drugs-revealed.aspx
  9. https://www.ncbi.nlm.nih.gov/pubmed/22390808
  10. http://blogs.naturalnews.com/the-truth-about-salt/
  11. http://skepdic.com/refuge/bunk28.html
  12. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31357-5/fulltext
  13. http://pharmamkting.blogspot.com/2008/01/statin-lottery-number-needed-to-treat.html
  14. https://statindecisionaid.mayoclinic.org
  15. http://circ.ahajournals.org/content/circulationaha/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf
  16. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31357-5/fulltext
  17. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61965-6/fulltext
  18. https://www.ncbi.nlm.nih.gov/pubmed/27353418?dopt=Abstract

Harriet Hall

Harriet Hall's photo

Harriet Hall, MD, a retired Air Force physician and flight surgeon, writes and educates about pseudoscientific and so-called alternative medicine. She is a contributing editor and frequent contributor to the Skeptical Inquirer and contributes to the blog Science-Based Medicine. She is author of Women Aren’t Supposed to Fly: Memoirs of a Female Flight Surgeon and coauthor of the 2012 textbook Consumer Health: A Guide to Intelligent Decisions.