Category Archives: LDL

Don’t Give More Patients Statins

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On November 14, the following editorial was published in the New York Times.

Don’t Give More Patients Statins

By JOHN D. ABRAMSON and RITA F. REDBERG

New guidelines published on Tuesday of last week widely expand the category of who should take statins.

Two physicians authored the article providing an excellent analysis and warning against implementation of the new guidelines which are unfortunately and again, not based on sound evidence or reasonable analysis.

” based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.”

“At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes  (especially for women),  cataracts or sexual dysfunction.”

“We believe that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy Americans. Instead of converting millions of people into statin customers, we should be focusing on the real factors that undeniably reduce the risk of heart disease: healthy diets, exercise and avoiding smoking. Patients should be skeptical about the guidelines, and have a meaningful dialogue with their doctors about statins, including what the evidence does and does not show, before deciding what is best for them.”

History repeats itself, soon the AHA and ACA will want statins in the water. The 18% estimate of serious side effects in my opinion is understated. Every week in the pain clinic I diagnose statin myopathy and/or cognitive impairment on at least one patient. Here are some stories about patients that appeared in the comments section of the oped on-line.

Noreen stated:

I am a victim of statin “therapy.” At the age of 72, with just a moderately high LDL, Simvastatin was prescribed. I took it for approximately 2 weeks, and severe pain developed in my whole body, but, primarily in my lower legs. I read the side effects on line and stopped taking it.
The pain went away, but my legs were weak. After much investigation by neurologists at University of California, SFMC, I was diagnosed with statin-induced neuropathy. The calf muscle in both legs has totally gone — nothing left but sinew. My life has been severely damaged by an inability to walk properly. I cannot raise on my toes. It has been three years since I took this medication, and there is no further hope of recovery. Prior to taking Simvastatin I was an athlete all my life. At the time of this pharmaceutical invasion I was still, hiking, exercising regularly and downhill skiing. Shame of this hired committee of “experts.”

Here is how a physician/patient described his experience.

I agree with Abramson and Redburg that treating a numbers instead of the patient is wrong. I am in a high risk group and I would hope to prevent another heart attack (I had one in 2009), yet I cannot take statins as I repeatedly developed muscle pain and then progressive weakness and loss of balance with all the statins I tried. My cardiologists (including Mayo physicians) and internists continued to push trying different statins and other cholesterol lowering medications even though I complained of side effects. Although some of my loss of power is due to aging and not statins, I used to be able to hike 10 to 20 miles with up to 5 to 6,000 feet elevation gain in a day before my statin era and now I can barely manage 4-5 miles at a slow pace. I’ve seen this in others taking statins. Even though the percentage who develop weakness may be low compared to the majority, it is a real debilitating effect for some. Doctors are brain washed (and the lay public too by TV and other ad bombardment), by the pharmaceutical industry to treat numbers rather than individuals. The result is the standard of care is now to treat the lab test instead of the person. Statins are dangerous medications and should not be prescribed lightly. SD Markowitz, MD

George from CA describes his experience as follows.

I had been on statins for over 15 years. Slowly, I began experiencing cognitive dysfunction, balance issues, muscle weakness, etc. even though I exercised both my body and brain. I quit several months ago and have been feeling better all around every day with improvement in every area. I’d rather die feeling good in 10 or 20 years than be miserable for however long this terrible medicine might extend my life.

JR Hoffman MD from Los Angeles provided further insight.

Congratulations to Drs Abramson and Redberg for their outstanding editorial, and to the NYT for having the courage to print it. As the authors note, this new guideline’s major beneficiary will be the pharmaceutical industry, while the American people will likely be its primary victim.

The British Medical Journal has recently printed a series of papers (disclosure — I co-authored one of those papers) addressing the biases and distortions that enter far too many published clinical guidelines, because a large majority of panel members and panel chairs have a financial conflict of interest, and because panels are stacked to support viewpoints reflecting those conflicts, independent of the evidence. This is particularly true of guidelines from prominent medical specialty societies … societies which themselves receive major financial support from industry. 

How many people targeted by the new guidelines would take one of these medicines if they were told that far more than 9 out of 10 (in fact probably more than 99%) would get no possible benefit whatever? And essentially none would get an overall reduction in major morbidity or mortality? And that this would come at a substantial cost in the side effects that a good many would suffer (not even considering the cost in dollars)?

If your physician tells you that you “need” a statin, please ask her for the details of how likely you as an individual are to benefit, and at what chance of harm.

Statin drugs interfere with the human production of many important substances. One of these is Coenzyme Q 10 also called uibiquinone. Co Q 10 functions as an important anti-oxidant and as an essential component of the apparatus inside every cell that produces ATP, the fundamental unit of energy that provides energy for every cellular function. Without ATP the cells in every organ shut down and cannot do any work.

Statin side effects can include not only muscle pain and weakness but also nerve damage, dementia, amnesia.  Shortness of breath can be the only symptoms when the muscles of respiration are affected.  Diabetes can be caused by any of the statin drugs and this can be permanent.  Rarely, statins can cause death . This happens when a massive amount of muscle damage causes a flood of debris that overwhelms the body’s ability to clear the debris. Damage to muscles and nerves can be permanent without any recovery after  the statin is stopped. A former astronaut and flight surgeon suffered transient global amnesia which fortunately cleared after stopping the statin drug. He has since published a few books about the dangers and inappropriate use of statins. Kidney failure requiring dialysis or kidney transplant is also a rare but potential result of statin medication.

Cardiologists and primary care physicians often ignore complaints about muscle pain, fatigue, weakness and forgetfulness in older patients and attribute it to old age. But even when these complaints are recognized as a side effect, rarely does a physician report it  to the FDA. As a result, post marketing surveillance data underestimates tremendously the frequency of side effects.

Be careful out there. Read my first post about statin medications. it provides risk-benefit data. Remember, we do not know with certainty the frequency of side effects and permanent damage, but you can be sure it happens more often than the drug company states. It happens more often than most physicians realize.

Peace

Bob Hansen MD

Number Needed to Treat (NNT) website and Statin Drugs

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My 85 year old mother-in-law was placed on a statin drug two years ago by her primary care physician. She had no risk factors for coronary disease other than age, she had a prior completely normal cardiac catheterization (coronary angiogram) and was totally without symptoms before being placed on the statin. Within weeks she developed muscle pain and weakness, suffered fatigue and overall felt poorly. I convinced her to stop the statin and within a few weeks she felt great. I see similar scenarios frequently in the pain clinic. I personally suffered severe statin induced myopathy pain from two different statins (in the days before enlightenment) and gratefully recovered when I stopped the drug each time. I have since learned more about coronary artery disease, cholesterol metabolism, statins, and related topics.

There is a great website that analyzes data from multiple studies to estimate the number of patients needed to treat in order to help and/or harm a patient. Two such analyses on this website are the NNT with statin drugs for five years to achieve certain results. They analyze data  in patients without known coronary artery disease (primary prophylaxis) and in patients with known coronary artery disease (secondary prophylaxis).

Here is the website:

TheNNT

Here is the page for primary prophylaxis:

Statins for Heart Disease Prevention (Without Prior Heart Disease) | TheNNT

Here is the link to the page on secondary prophylaxis:

Statins for Heart Disease Prevention (With Known Heart Disease) | TheNNT

Here are the results for primary prophylaxis.

“In Summary, for those who took the statin for 5 years:

  • 98% saw no benefit
  • 0% were helped by being saved from death
  • 1.6% were helped by preventing a heart attack
  • 0.4% were helped by preventing a stroke
  • 1.5% were harmed by developing diabetes*
  • 10% were harmed by muscle damage

In Other Words:

  • None were helped (life saved)
  • 1 in 60 were helped (preventing heart attack)
  • 1 in 268 were helped (preventing stroke)
  • 1 in 67 were harmed (develop diabetes*)
  • 1 in 10 were harmed (muscle damage)”

Here are the results for secondary prophylaxis.

“In Summary, for those who took the statin for 5 years:

  • 96% saw no benefit
  • 1.2% were helped by being saved from death
  • 2.6% were helped by preventing a repeat heart attack
  • 0.8% were helped by preventing a stroke
  • 0.6% were harmed by developing diabetes*

In Other Words:

  • 1 in 83 were helped (life saved)
  • 1 in 39 were helped (preventing non-fatal heart attack)
  • 1 in 125 were helped (preventing stroke)
  • 1 in 167 were harmed (develop diabetes*)”

If anything, the side effects (harm) are understated and the authors acknowledge this because many of the studies do not adequately report side effects and complications. (The studies were funded in part or in totality by the pharmaceutical company that makes the drug and that is a problem as discussed below)

Association of funding and conclusions in randomized dr… [JAMA. 2003] – PubMed – NCBI

It is rare that this sort of analysis would be presented to a patient in the physician’s office to help a patient decide whether the risks and benefits are acceptable. (I provide patients with this data on a multi-page handout with significant narrative and explanation when I diagnose statin myopathy.)

The obsession that American physicians have with cholesterol (another topic to be addressed in future posts) creates a knee-jerk reaction to a lab value that results too often in muscle damage and pain and sometimes cognitive impairment.

My experience in the pain clinic has been that the % of elderly with statin induced muscle damage and/or muscle pain is much higher. When I suggest that the patient stop the statin drug because they are suffering disabling pain and possibly permanent muscle damage they often return at the next visit to tell me they were started on a different statin drug. Most patients who suffer this complication will have a repeat of the same complication when placed on a different statin drug. This complication can cause permanent damage.

In the medical literature, many studies presented as “primary prophylaxis” are not truly primary prophylaxis because there are some patients included that have known diagnosed coronary disease. This tainted data is then presented as if it were a true primary prophylaxis study.

A more recent study purported to demonstrate once and for all that statins in primary prophylaxis can save lives. Unfortunately, there were problems with this study as well. Here is an excerpt from a commentary in the publishing journal:

“There are reasons to be cautious about the findings of the meta-analysis by Taylor and colleagues. As the authors note, all but 1 of the trials were partly or fully funded by pharmaceutical companies. Trials funded by for-profit organizations are more likely to recommend the experimental drug than are trials funded by nonprofit organizations (4). Further, adverse event reporting in the original trials was poor, with few details about type or severity, and quality of life was rarely assessed. Some adverse events, such as cognitive impairment, are rarer and not assessed.”

Disappointingly, the commentary failed to point out that the study data again included some patients with diagnosed coronary artery disease. (up to 10%).

Here are the authors own words.

“We included randomized controlled trials of statins versus placebo or usual care control with minimum treatment duration of one year and follow-up of six months, in adults with no restrictions on total, low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD.”

Once again we have a “primary prophylaxis” meta-analysis that is not really a primary prophylaxis study. It never seems to end.

When drug companies fund studies the conclusions often overstate the benefit and understate the risks. If you do not look for a side effect or complication, you will not find one. Here is an excerpt from a large study that look at the issue of bias in drug company sponsored research.

“CONTEXT:

Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions.

OBJECTIVE:

To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events.

CONCLUSIONS:

Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.”

Association of funding and conclusions in randomized dr… [JAMA. 2003] – PubMed – NCBI

There are many ways that authors can present data to give the appearance of success. A more recent study published in Lancet alleged to demonstrate benefit (death prevention) for statins in primary prophylaxis.

Here it is.

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 : The Lancet

But when you drill down into the data you  discover a mechanism of deception. The benefits reported in the paper applied only to patients whose cholesterol dropped significantly. Looking at all patients in the study who took the statin did not result in decreased death rates. Selecting those whose cholesterol dropped 40 points did show death prevention benefit. They presented risk reduction per unit of cholesterol reduction. From a scientific point of view this is less than honest. The authors simply demonstrated that patients who responded to the drug benefited.

DUH***All previous studies that simply compared patients on statins vs. those not on statins (primary prophylaxis) showed no prevention of death. This is an important distinction, The cost implications of putting low risk individuals on statins are enormous. Statins also rarely can cause death (from rhabdomyalysis) and frequently caused harm.  One comment about this studies’ conclusions was titled “Statins for all by the age of 50 years?” That frightens me.

The mechanism of statin drug benefits are likely related to many known potentially beneficial physiologic effects, not from a reduction of cholesterol. As you will learn in future posts, cholesterol reduction in and of itself is almost meaningless. The amount of circulating cholesterol in your blood is not the problem. The problem is much more complex and relates in part to the oxidation of LDL particles, which has little to do with the amount of cholesterol carried in those particles. Other important factors include systemic inflammation and the response of the innate immune system to factors such as circulating LPS which in turn reflects intestinal permeability. I apologize for the sudden onslaught of abbreviations and medical terms but stay tuned and you will learn what they all mean.

Finally, in the secondary prophylaxis group, the benefits of statin drug use are equivalent to the benefits achieved with exercise-based cardiac rehabilitation following a heart attack. Cardiac rehab offers many benefits in addition to saving lives, produces no significant negative side effects, and improves quality of life and sense of well-being. Many patients on statins feel lousy.

Efficacy of exercise-based cardiac rehabilitation… [Am Heart J. 2011] – PubMed – NCBI

In my next post I will discuss saturated fat  and coronary artery disease. This issue represents the crux of controversy in the heart-healthy diet debate which most physicians and the AHA consider clarified (eat less saturated fat). You already know generally what I have to say about that if you have read my Manifesto page. The next post will expand on the saturated fat section in the Manifesto. Subsequent posts will discuss cholesterol, LDL cholesterol, LDL particle number, oxidized LDL and glycated LDL (the last two are referred to as modified LDL)

Bob Hansen MD