3 Reasons Why You Should Be Skeptical of the New Cholesterol Guidelines

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I’m sure you’ve heard by now that the leading heart organizations in the U.S. have released updated treatment guidelines for cholesterol-lowering drugs (statins). The changes include discarding the specific numerical targets that have been used to monitor treatment for decades and recommending a statin for everyone with a 10-year risk of heart attack or stroke of 7.5% or higher, as determined by a new risk calculator.

The new guidelines have received a lot of media attention of the past several days, including criticism from no less than the former president of the American College of Cardiology. I’m happy to see this, because as I will argue in this article, the new guidelines are problematic and would put millions at risk due to unnecessary and prolonged treatment with statin drugs.

Here are 3 reasons why you should be skeptical of the new cholesterol and statin guidelines.

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#1: They dramatically overestimate risk

Two Harvard Medical School professors, Dr. Paul M. Ridker and Dr. Nancy Cook, have pointed out that the new risk calculator overestimates risk by 75 to 150 percent, depending on the population. (1) For example, a man whose risk was actually 4 percent might show up as having an 8 percent risk—which would move him from the “no treatment recommended” group to the “prescribe a statin” group.

Dr. Steven Nissen, a former president of the American College of Cardiology, entered information for some hypothetical patients into the new risk calculator to see what it would recommend. He was shocked to find that the calculator showed a risk of 7.5 percent for a 60 year-old healthy African-American non-smoking male with no risk factors, a total cholesterol of 150, HDL of 45, and systolic blood pressure of 125. He also found that the calculator suggested a risk factor of 7.5 percent for a 60 year-old healthy white male with no risk factors. If we use this new calculator, Dr. Nissen said, it would lead to almost all healthy men over the age of 60 getting treated with a statin, even if they’re in the lowest-risk group. (2)

#2: They’re based on flawed, incomplete, or outdated evidence

In an excellent paper in the journal Mayo Clinic Proceedings, Dr. Allan Sniderman and colleagues argue that so-called “evidence-based medicine” is problematic because of limitations in the evidence used as the basis of treatment guidelines and recommendations. (3) As an example, he points to the role of statins in primary prevention (i.e. prescribing statins to healthy people without pre-existing heart disease as a means of preventing it). Most doctors now believe that the highest doses of statins are the best choice solely on the basis of a single meta-analysis (an analysis of several individual studies) that involved 5 dose-comparison studies. However, as Dr. Sniderman points out, the meta-analysis is flawed and does not support the conclusion that higher doses of statins are more effective than lower doses for prevention of heart disease in healthy people.

Another problem is that treatment guidelines are often based on outdated evidence. This turns out to be the case with the new risk calculator, which uses data from studies performed two decades ago to determine how risk factors like cholesterol and blood pressure predict actual heart attacks and strokes later in life. Data from these studies are no longer valid because the participants are from a different era with different behaviors and risk. For example, in the early 1990s more people smoked and heart attacks and strokes occurred earlier in life.

#3: They’re subject to conflicts of interest

Numerous studies have shown that conflicts of interest are a real problem in scientific research. (4) According to Lisa Cosgrove, an associate professor at the University of Massachusetts, “When individuals have commercial ties they are vulnerable to developing subtle, but sometimes powerful, pro-industry ways of thinking.” (5) Dr. David Antonuccio put it even more plainly in his excellent article “Antidepressants: A Triumph of Marketing Over Science”:

Company-sponsored experts, whether they are researchers or educators, are by definition company employees. They will be retained only if they offer consistently favorable treatment to the company’s products.

This explains why groups like the Institute of Medicine recommend minimizing or eliminating conflicts of interest in guideline development groups. They wrote that, “whenever possible, guideline development group members should not have conflicts of interest… and the chair or co-chairs should not be a person(s) with conflicts of interest.” (6)

The American Heart Association and American College of Cardiology did not follow the sensible recommendation of the Institute of Medicine when they assembled their expert panel. Of the 15 panelists that authored the new guidelines, 6 reported having recent or current ties to pharmaceutical companies that sell or are developing cholesterol-lowering medications. Among the companies listed are Merck, Amgen, AstraZeneca, Pfizer, Amarin, Roche, and Abbot Laboratories. (For a full list of disclosures, see page 51–57 of the new guidelines.)

Strangely enough, I’ve seen some people criticizing the idea that conflicts of interest would affect statin prescriptions because most statins are no longer protected by patent are thus not profitable for drug manufacturers. Nothing could be further from the truth. Over the past 5 years, statin prescriptions in the U.S. have grown 20 percent to 264 million a year (a shockingly high number in a country with a population of 314 million). Total global sales of cholesterol-lowering medications, including statins, were $35 billion in 2012. Statin sales amounted to $29 billion worldwide and $10 billion in the U.S. (7) Those are enormous figures. In fact, statin drug sales account for approximately 10% of all drugs sold in the U.S., with a single statin (Lipitor) generating almost $8 billion in sales alone. (8) I think it’s pretty safe to say that drug companies are making a killing selling statins.

30 years ago the then-CEO of Merck (Harry Gadsen) told Fortune Magazine that he wanted Merck to be more like chewing gum maker Wrigley’s. It had long been Gadsen’s dream to make drugs for healthy people so that Merck could “sell to everyone”. (9) If implemented, these new cholesterol guidelines would certainly help Gadsen’s vision to become a reality.

Fortunately, it appears that the guidelines as currently designed won’t be accepted due to serious flaws that have been pointed out by leading cardiologists around the country. In the meantime, if you’re wondering what to do (or not do) about high cholesterol, make sure to read my recent series called The Diet-Heart Myth.

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Comments Join the Conversation

  1. JoAnne says

    Nice summary. I was also happy to see that the former head of the American College of Cardiology spoke out against it. And I’m glad that the New York Times is highlighting the subject so much.

    Now I’m off to figure out how to RAISE my cholesterol, since my tests just came back and I’m only at 138. HDL is 36. Yikes! If anyone out there has advice for me, I’d love to hear it.

    • Chris Kresser says

      In a minority of people eating more saturated fat and dietary cholesterol will increase total, HDL and LDL cholesterol levels.

      If you’re already doing that, the next thing to do is look at liver function. That’s where lipoproteins are produced.

      • Jose marti says

        The fundamental reason Mr Kresser,and something you are very much aware,is that cholesterol has nothing to do with heart disease,zip.

      • JoAnne says

        Thank you for the reply. I do consume a lot of saturated fat already, so I will have my doctor look into liver function. My total cholesterol usually hovered around 190-200 before, so this drop must have been precipitated by something.

    • DM says

      JoAnne, I would suggest to start consuming coconut oil. Coconut oil is often a modulator of cholesterol levels – raising when needed and lowering when needed.

      I would start with a teaspoon a day and go up from there listening to your body. Some people need to stay at a teaspoon a day and some people may need 3, 4, or even 5 tablespoons a day. Everyone is different, you have to see what works for you.

      Typically if you thrive on more protein and fat you will need and thrive on several tablespoons a day, on the other hand if you thrive on more vegetables and less protein and fat, you probably need and thrive on less than a TBSP/day.

      About the subject of this article, I know people I work with say they have gotten the impression that the new guidelines will lessen statin usage. However, this is the second article Ive read that indicate they will massively increase statin usage as verified by Dr. Nissen. I think the corporate (big pharma) controlled media is probably presenting a much more rosy picture on this subject than the reality. Thats Typical. Unfortunately, ignorant, unteachable, stubborn doctors who refuse to change their mind about anything they learned in medical school, regardless of how stone-age or the actual evidence, will go by these guidelines which will ruin the health of millions. I think if modern doctors were taught blood letting in medical school they would be whole hearted proponents. We need medical doctors who are not naive parrots and who will actually think and read and question. Our medical industry is a disaster. These guidelines are obviously industry driven (i.e. to make more money) and it just shows how in control the corporations really are – especially the big pharma companies. Statins are the biggest money making drug in history and this shows its never enough, the greed of big pharma knows no bounds, even destroying the lives of millions of people, big pharma doesnt care one bit as long their stock price goes higher. When will we wake up???? The only way to stop them is to stop buying their pathetic excuse of a product we call prescription medication. These medications which are used by almost all elderly people and a growing subset of children are poisonous pseudo-remedies and will never be able to compete with real medicine found in food, herbs, supplements, and lifestyle.

      Folks, stay away from statins, they are poison and do practically nothing for heart disease. The real research shows they are less than 1% effective but will cause significant seriously damaging side effects at least 20% of the time (I think much higher actually). How SAD! Tell your doctor to go do some actual research on the subject instead of being a naive parrot.

      Regards.

      • JoAnne says

        Thank you, DM. I did see on Mercola’s website that he suggested coconut oil, too. I will start adding it, slowly as you suggest. Where I live, I haven’t been able to find virgin coconut oil, only refined stuff, so this is good timing since I’ll be traveling soon and can pick some up on my trip. Thanks again!

    • Susan Zeitler says

      JoAnne, not to scare you, but I thought I would just give info that I am aware of. Low cholesterol can be a sign of cancer. When my husband had testicular cancer, his cholesterol level was 126, as this fact held true for him. It was the only variable that was abnormal on his lab work.
      I assume you were not on a statin or cholesterol lowering med…I am unsure at what level, cholesterol is considered abnormal.

    • Honora says

      Apo E genotyping can apparently categorize the way the body responds to changes in amounts of various fats e.g. fish oils versus saturated fats. (BTW, yes I know fish oils also contain saturated fats). In my case – Apo E 3/3, an increase in saturated fats raises my HDL and I think from memory lowers the dense nasty LDL. The chart is at my work!

      I got my apo E genotyping done through 23andme who also mapped 0.1% of my genome. A huge amount of data to enjoy.

  2. prioris says

    if someone is concerned about heart disease and strokes and even alzheimers, they should be taking fibrolytic enzymes such as nattokinase. The entire cholesterol thing is a red herring and should be discarded into the waste basket.

  3. J says

    Here’s how silly the “risk calculator” is: With systolic of 119, my risk was 5%. With systolic of 120 but everything else held constant, my risk rose to 36%. Scary to think any doctor would prescribe statins based on that!

  4. Mike says

    While I’m sympathetic to the perceived “bias” that comes from working with big pharma, I think it is a mistake to categorize all “conflicts of interest” as problematic. Bias is an inevitable aspect of human nature. If not biased toward one’s employer, one might be biased against perceived “corporate greed”, or biased toward upsetting the status quo, or biased toward publishable results.

    In similar contentious issues (in my case, with environmental issues), the use of consensus-based, multi-stakeholder groups are much more likely to produce objective science because they various interests and biases can be flushed into the open and explored using scientific methods.

    In short, discounting a result because of perceived bias is a weak argument because ALL studies carry with them a perception of bias from some constituency groups.

    But I generally agree that this particular study has some pretty serious flaws…

    • Tom Jeanne says

      Well said. Intellectual conflicts of interest abound as well. If researcher (or blogger) X has spent years believing certain hypotheses, he or she will have a bias towards their view and against competing views. This is a real issue for all of us, because its essentially impossible not to take sides in most issues, and many issues have insufficient unbiased evidence. But yeah, I think it’s more than just my bias that these new guidelines are biased! :)

    • Andrew MacDowell says

      You have made a very important point Mike. An intelligent, wise and objective approach sees the bias in the Big Pharma-controlled medicos and health boards, in the self-serving, often incompetent, uncaring and lazy medical ‘professionals’ who rely on grossly incorrect medical dogma but, also, crucially, the powerful, anti-business, anti-free enterprise and pro Big State – anti-Pharma whatever they do – political movement. Pharmaceutical companies have produced many, many, excellent medical advances that have helped hundreds of millions of people; we have to weed out the minority of corrupt and ruthless people and companies but we also have to appreciate the majority of good ones. This view never has an airing on this site because it is as biased as the Big Pharma controlled medical boards and doctors that it it so rightly criticizes.

      Mike puts the case excellently:
      “In similar contentious issues (in my case, with environmental issues), the use of consensus-based, multi-stakeholder groups are much more likely to produce objective science because they various interests and biases can be flushed into the open and explored using scientific methods.

      In short, discounting a result because of perceived bias is a weak argument because ALL studies carry with them a perception of bias from some constituency groups. ”

      I know the Pharma-bashers on here won’t like this comment because they enjoy the ranting of the single-minded ideologue – and attacking big business is so fashionable. Here in Britain we see the constant cases of appalling treatment of patients and the corruption that State-controlled medicine creates but the pro Big State establishment and media focus their attacks on private enterprise.

    • Chris Kresser says

      I agree that it’s impossible to eliminate bias and that it exists everywhere in research. But that doesn’t mean we shouldn’t try to minimize financial conflicts of interest, especially when it comes to creating guidelines for drug prescription. That’s just common sense, and it’s why groups like the IOM have advised that groups responsible for creating guidelines at the very least avoid having co-chairs with conflicts of interest.

    • Ginny says

      Mike said:

      “In short, discounting a result because of perceived bias is a weak argument because ALL studies carry with them a perception of bias from some constituency groups.”

      In this particular study, there is more than just a “perceived bias”. It’s blatantly biased. So much so that there are MD’s arguing against it in order to protect their own credibility. As well they should!

      The point I want to make here is this: just because bias exists (as a fundamental human flaw, imho) does not mean we need to excuse it. Partiality toward a particular group is THE problem; a problem that keeps the truth hidden. I’m so grateful for those few conscientious MD’s who will stand up for the truth, loudly, and risk having their reputations within the medical community (the status-quo) tarnished.

    • Honora says

      Yes, I read of a study recenlty where the group of excercising elderly folks on statins had their mitochondria go down by 13% on statins whereas the group who weren’t on statins had an increase in mitochondria.

      • JC In KC says

        The university of Missouri Study is interesting, but it would have been even better to see another arm of patients that were on a statin and supplemented with CoQ10 to help with mitochondrial repair.

  5. David B says

    Yes to coconut oil for raising HDL! I started eating it eight years ago. HDL in the first blood test after beginning went up to 111. It has ranged from 92 to 119 and averages 107 over the 8-year period. All of the cholesterol numbers and ratios are excellent. I’m now almost 71 (male) and eat about 3 tablespoons daily.

    It’s worth a try.

    • prioris says

      what the latest studies say now is that the bad cholesterol is also good especially as people grow older. so many people are trying to address a problems that is irrelevant to their heart health. if you want a healthy heart, take fibrolytic enzymes like nattokinase.

  6. Carlos says

    My LDL cholesterol is 295!! My doctor says thuis rate is very very elevated and this is unhealthy.
    Is this rate dangerous for my heart? What can I do apart taking statins?

    • Gareth says

      Cholesterol ratios and especially the ratio between HDL and Triglycerides are said to provide a much more accurate picture of cardiovascular risk, according to the latest research. Carbs in excess will lower your HDL (bad) and raise your Triglycerides (bad). LDL also has a couple of types, one considered to be harmful and the other not. This calculator is quite useful in getting a much clearer picture.

      http://www.hughchou.org/calc/chol.php

      Cut out fructose(see “sugar, the bitter truth” on youtube and know it is in most sweet drinks) and simple carbs( white anything and most fruits). Eat low GI carbs (beans, veges etc) but not in excess and eat better fats, saturated or unsaturated. Avoid trans fats at all cost. Above all exercise daily and hey, a glass or two of red wine also does wonders.

  7. Sue says

    In arguing that statins are still profitable, even if off-patent, you state:

    In fact, statin drug sales account for approximately 10% of all drugs sold in the U.S., with a single statin (Lipitor) generating almost $8 billion in sales alone. (8) I think it’s pretty safe to say that drug companies are making a killing selling statins.

    The “almost $8 billion” cited in your footnote (8) is from 2010 and 2011. Lipitor didn’t go off-patent until November, 2011. Is Pfizer still “making a killing” on Lipitor?

  8. Ginny says

    I was placed on a statin about two years ago, and when my liver enzymes began to climb, I told my doctor I was not going to take it anymore!

    So glad to see this article, and even more glad to know that there are conscionable doctors who will blow the whistle when need be. It needs to happen far more often.

    However, this article begs the question: is there any of this same behavior going on within the Paleo community?

  9. Cheena says

    I am 49 years old and healthy with the exception of heterozygous familial high cholesterol. I have been taking the max dosage, 40 mg, of rosuvastatin for over a year. Today I am in bed with excruciating lower back pain and joints have been hurting too. My sister died from a fatal heart attack just before her 55 th birthday. Toying w/ going off statins, but I don’t know if that is foolish or not. Is it always absolutely necessary to be on statins with familial high cholesterol?

    • prioris says

      Have you taken the time to read the comments above ?

      Have you taken the time to read the research regarding high cholesterol and heart attacks ? There is no correlation.

      Have you taken the time to look into Statins ? They damage your health. Blood pressure varies all day long. Low blood pressure is what you need to avoid.

      Give up your medication and take nattokinase on empty stomach. This will protect you against heart attacks and strokes.

      For your back pain – Take a good highly absorb-able Hyaluronic Acid – biocell has a good version. Doctors Best HA is one example. Not only your back will feel better within a couple weeks but your joints will also. Take at least 150 mg of HA per day on EMPTY stomach .

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