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Cholesterol guidelines – what went wrong?

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The 2013 cholesterol guidelines are just that … guidelines. Healthcare providers will make the final decision as to whether or not they will follow the guidelines in the treatment of high cholesterol or more specifically elevated LDL’s (bad cholesterol).

To add to any hesitation about using the cholesterol guidelines in patient treatment, the mere credibility of the guidelines is in question. Although the 15 panelists that authored the new cholesterol guidelines considered scientific evidence based on research over a 5 year period to develop the guidelines, they have not been universally accepted as the be-all to end-all treatment in the fight against heart disease in the presence of elevated blood cholesterol levels.

The reasons for this credibility gap include, in part:

  • The research referenced by the committee relied on results of previously published randomized controlled clinical trials but, according to some critics, ignored other confounding factors or data that may have led to completely different set of standard criteria. Results from previous studies can be as old as one or two decades, making this evidence inaccurate. In one article explaining why we should be skeptical of the new cholesterol guidelines, the author, Chris Kresser, writes “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 Data from these studies are no longer valid because the participants are from a different era with different behaviors and risk.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”.
  • Funding for the review of existing additional clinical trials and for additional new research, focusing on specific aspects of the recommendations, was minimal and underfunded for such an important project. What started out as an investigation answers 18 questions to various factors ended up only being three questions. When discussing the funding, Dr. Elizabeth G. Nabel, who was the former Director of the US National Heart, Lung, and Blood Institute (NHLBI) at the US National Institutes of Health (NIH), for much of the time during the project stated, “This is one of the untold consequences of budget reductions,”
  • The ultimate outcome of such guidelines is to change public opinion and ultimately public policy. According to Dr. Steven Nissen, a Cleveland Clinic cardiologist and past president of the American College of Cardiology, “This was a catastrophic misunderstanding of how you go about this sort of huge change in public policy.”
  • The guidelines offered a departure for current standards and well accepted fundamental medical practices both in the US and abroad. There are a variety of risk calculators currently used in Europe and according to Dr. Michael Lauer of the National Heart, Lung, and Blood Institute, countries within Europe use different calculators.
  • There was little or no opportunity for shareholders, such as medical care providers, scientist, researchers, insurance providers, medical institutions and the general public to engage in public debate before announcing the guidelines at the annual meeting of the American Heart Association, under a perceived cloak of secrecy.
  • Discarding the standard practice of routinely monitoring LDL cholesterol once patients were placed on statin therapy also fell under criticism by physicians. The National Lipid Association, a respected authority in the medical community which represents specialists in lipid disorders like high cholesterol, and who initially worked with the group, publicly disagreed with LDL recommendations.
  • The recommendations for the use of statin drugs as the only drug therapy found effective for the treatment of elevated LDL’s eliminated other popular and well documented pharmaceutical therapies as effective. As referenced in a previous examiner article, “if implemented by the medical community, this could result in millions of individuals now being placed on high intensity statin therapy, that previously would not have been considered for statin therapy. This would also mean that these individuals would be exposed to the side effects of statin therapy.” Disclosures within the guidelines also raised the suspension of conflict of interest when it was revealed that 6 of the committee members had previous, recent or current associations to the “same pharmaceutical companies that sell or are currently developing cholesterol-lowering medications”.

The revised cholesterol guidelines also include the use of a new risk calculator for targeting larger numbers of patients for statin treatment. However this calculator has its own critics. Based on an article by Ridker and Cook the risk calculator is being challenged for not having "been prospectively tested for its accuracy in predicting cardiovascular risk" and it "appears to overestimate observed risks". The guideline developers disagree.

In a journal article, Dr. Paul M. Ridker and Dr. Nancy Cook, two Harvard Medical School professors, also noted that "the new risk calculator overestimates risk by 75 to 150 percent, depending on the population. This overestimated risk can move patients who would not have previously been categorized as ... no treatment recommended, to ... prescribe a statin”.

As noted in a article, after testing the new risk calculator for hypothetical patients, Dr. Steven Nissen, a former president of the American College of Cardiology, concluded that; “If we use this new calculator, 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.

This information is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical/nutritional/fitness advice. Information presented is subject to change as additional discoveries are made or additional research is published.

Additional information:

Sources:,,,,,,,,, The Lancet. Comment published online November 19, 2013



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