Statin Guidelines, one step forward, two steps backwards

The new statin guidelines published jointly by the AHA (American Heart Association) and ACC (American College of Cardiology) present some good news but also allot of bad news.

The good news (one step forward) is that the guidelines acknowledge the following:

1. None of the cholesterol lowering drugs (except for statins) have ever demonstrated the ability to save lives by lowering cholesterol.

2. The ability of statin drugs to save lives (after a heart attack) is independent of whether and by how much the cholesterol is lowered.

This acknowledgement is very important because it sheds light on the fact that statins work primarily by effects independent of how much cholesterol is circulating in the blood. This is a fact that is not well understood by many physicians or patients. This fact will create some confusion because the American public has been misinformed for many years by physicians, the media and professional organizations all using terms like “good cholesterol” and “bad cholesterol”. These terms are meaningless, confusing, and counter-productive.

The new guidelines are two steps backwards for a few reasons:

1. They expand the number of patients under the guidelines in the US by tens of millions of people who will not benefit from their use and implementation of the guidelines will likely harm many.

2. The guidelines continue to assume and quote unrealistically low and inaccurate complication rates.

3. The risk assessment tool that accompanies the guidelines over-estimates risk for heart attack and stroke by 75-150%. This calculation of the over-estimate is based upon application of the guidelines to a huge database of real patients. This analysis has been published in a Peer Reviewed Journal and this analysis has already been discussed by the lay-press to the embarrassment of the AHA and ACC. This particular concern was communicated to the guideline committee one year ago by a prominent research cardiologist and statistician on the faculty of Harvard Medical School, but ignored by the guideline committee.

4. The guidelines have lowered the recommended 10 year  risk threshold for use of statins from the previous 10-20% level to a 7.5% level (thereby tremendously increasing the number of people who would be placed on statins). And since the risk calculator, as discussed in #3 above, greatly inflates the risk it essentially would apply the statin guidelines in reality to individuals with only a 3.75 to 4% risk of a cardiovascular event in the next 10 years. This shifts the risk/benefit ratio to a much higher level than the already high risk/benefit ratio of the previous guidelines.

Gratefully the excessive use of statins as well as the folly of the previous and new guidelines have  been brought to the public arena and the debate has finally drawn attention. Perhaps some reasonable discussion will ensue and perhaps the medical community at large will finally think about the bias represented in policy statements and guidelines as well as the bias presented in the many review articles that have been published on this topic.

Here are links to some reading of recent articles in the lay press.

Cholesterol Guidelines Under Attack – NYTimes.com

New Cholesterol Advice Startles Even Some Doctors – NYTimes.com

Risk Calculator for Cholesterol Appears Flawed – NYTimes.com

“After the guidelines were published, two Harvard Medical School professors identified flaws in the risk calculator that apparently had been discovered a year ago but were never fixed, as Gina Kolata reported in The Times on Monday.

In a commentary to be published Tuesday in The Lancet, a leading medical journal, the professors estimate that as many as half of the 33 million do not actually have risk thresholds exceeding the 7.5 percent level. Other experts who have tested the calculator found absurd results; even patients with healthy characteristics would be deemed candidates for statins.”

Be careful out there.

Peace,

Bob Hansen MD

10 thoughts on “Statin Guidelines, one step forward, two steps backwards

  1. bitwisemd

    How do you address the enormous body of evidence showing that statins impart benefit on mortality and morbidity? Here are a select few titles from the key literature.

    – The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials.

    – Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial.

    – The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials.

    – Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis.

    – Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials.

    http://www.tripdatabase.com/
    http://www.ncbi.nlm.nih.gov/pubmed/

    Reply
    1. Bob Hansen MD Post author

      Thanks for your comments. The problem with the meta-analyses of primary prevention trials is that they include secondary prevention data. So many of the original primary prevention trials were mixed primary/prevention but titled as primary prevention that I have grown very skeptical of any new meta-analysis that comes along, including those you have cited and which are guilty of the same problem. But the real issue is not whether in high risk groups statins can prevent cardiac morbidity and mortality, but what are the risks/complications and how often are they permanent? Unfortunately there has been a strong bias recognized in the Cochrane reviews that have concluded that in many studies side effects were not reported or under-reported. Furthermore, the FDA post-marketing surveillance similarly and dramatically understates the frequency and severity of side effects and complications. I have never taken the time to report a statin complication to the FDA, have you? I have without exaggeration diagnosed a statin myopathy on a weekly basis in the pain clinic. Most often it is an elderly woman who was told by her prescribing physician that her fatigue, weakness and muscle pain were due to old age and arthritis. Yet within weeks of stopping the statin they return to report that “I have my life back”. After observing this for years I decided to investigate the data on statin side effects and complications and was shocked to discover the degree to which this has been under-reported. I deplore the financial conflicts of interest built into the committee system that promulgates public health policy recommendations in this and other areas. The fact that statins are now available as generics is meaningless, it does not negate decades of unreported and under-reported complication rates, publication bias, reporting bias, interpretation bias and guideline bias. When I provide NNT information to patients already on statins they ask me why their physician did not provide this to them when the prescription was written. I have never, not once, encountered a patient on a statin who was aware or informed of this data by the prescribing physician. Our duty is to first do no harm and unfortunately, because of decades of bad data, we still do not fully understand the iatrogenesis we are perpetrating by excessively prescribing this class of drug. I will provide in a future post, more data on statin complications.

      Reply
  2. bitwisemd

    I just realized, I completely misinterpreted your original post. ^_^ I thought you were making the claim that “statins” don’t improve mortality as a primary outcome. That’s what I get for reading on my phone.

    Thanks for the thoughtful reply. And, I appreciate your skepticism.

    Reply
  3. rdfeinman

    Good post and excellent reply above. I think that the real question is, shouldn’t this debate have taken place before we rushed to put everybody on statins? Additionally, although the AHA/ADD committees list their conflicts of interest and even if we assume that the drug companies had no influence on their opinions, is it not reasonable to think that they have made a big intellectual investment in the statin picture and that it is unreasonable for them, in essence, to be judging themselves? Don’t we need a neutral committee. And their critics, like you and me, have credentials and they have been consistently good at ignoring their critics. I think the end-users have to start asking for real dialogue and neutral evaluation.

    Reply
    1. Bob Hansen MD Post author

      Well stated, neutral committee recommendations are vitally needed but unlikely to come unless thoughtful critics such as yourself are heard. We must keep trying.

      Reply
  4. Rich Svoboda

    I read an article about using vitamin C instead of statin drugs. Is this credible? Certainly the statins are more expensive and have negative effects. Neropathy, muscle damage, fatigue, and diabetes risks taking statins when one has diabetes and what I thought was neropathy from diabetes seems to be an approach that complicates the existing health issues.

    Reply
    1. Bob Hansen MD Post author

      Unfortunately there are no studies that support the use of Vitamin C to prevent heart attack or stroke. Once you have had a heart attack there are some clear benefits to statins in decreasing risk of a second heart attack, but the risk vs. benefit is subject to an individual’s personal assessment of benefits vs. potential side effects and complications.

      Reply
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