Statin Update

Filed in Articles and Presentations on July 7, 2014

Statins were originally discovered as a side effect of a failed antibiotic drug.  They were quickly marketed to the cardiologist as beneficial for acute heart cases where often the lifestyle especially that of poor diet and no exercise had contributed to atherosclerotic arteries.

Statins do not remove existing atherosclerotic plaques but they may inhibit increased deposition by reducing the level of circulating cholesterol in the body. This marketing tool was quickly taken up by doctors as they make no effort to spend time with patients on dietary and exercise habits as they themselves often have inadequate or no training in these subjects. Big Pharma used statins as a means of the medicalization of large numbers of people when in fact they did not need it.

So let us start with the mechanism of a statin drug.

  1. It Inhibits  the normal function of the mitochondria ( energy sector of each cell )
  2. By interfering with the mitochondrial wall it Releases free radicals known pre cursors for all chronic diseases. Istvan ES, et al.J. Department of Biochemistry, Howard Hughes Medical Institute, University of Texas Southwestern Medical Center at Dallas, TX 75390-9050, USA. Mol  Pharmacol. 2009 Jun;75(6):1421-9.
  3. It Interferes with the signalling requiring control of insulin and results in creating diabetes type 2. April 5, 2011 issue of the Journal of the American College of Cardiology  Dr David Waters et al meta analysis; Statin Therapy and New-Onset Diabetes: Molecular Mechanisms and Clinical Relevance. Banach M, Malodobra-Mazur M, Gluba A, Katsiki N, Rysz J, Dobrzyn A. Curr Pharm Des. 2012 Dec 26. Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statins trials. Lancet 2010; 375:735-742
  4. Interferes with the production  of all steroid hormones, sex hormones, vitamin D, and the immune system by lowering the amount of cholesterol that the body needs to make these products essential to human life. ( Biochemistry 5th Ed Berg et al )
  5. Weight gain.  It was found that compared with statin nonusers, statin users significantly increased their fat intake and calorie consumption, along with their BMI, in the last decade. This article raises concerns of a potential moral hazard of statin use, in addition to the already known adverse effects. Focusing on cholesterol levels can be distracting from the more beneficial focus on healthy lifestyle to reduce heart disease risk.  Rita F. Redberg, MD, MSc  JAMA Intern Med. Published online April 24, 2014. doi:10.1001/jamainternmed.2014.1994

This year the FDA, admitted as did the American society of Cardiologists, that a statin cannot control HDL:LDL by its mechanism of action.  This analysis has always been a complete red herring not to mention false advertising as the body alone controls the conversion from HDL to LDL or vice versa.  For those of you who regularly get blood work your HDL;LDL is commonly broken out as a rationale for giving a statin drug.  It is not a sound medical basis to prescribe a statin drug and there is no scientific evidence that it does this.

At the beginning of this year that same society (ASC) endorsed the introduction of more generous guidelines for prescribing a drug which is known to cause diabetes the no.3 killer in our lifetime. In the US and the UK a significant number of responsible doctors have challenged these guidelines and the discussion is ongoing.  This is a very rare occurrence to have such a debate amongst medical professionals in the public domain.  It reflects the deep professional disquiet on the lack of evidence and the knowledge that the patient is increasingly informed thus challenging the assumed superiority of MD’s.  Below is a quote from the letter sent to NICE by a group of physicians. NICE is a national UK regulatory body.

Dr David Newman, Assistant Professor of Emergency Medicine and Director of clinical research at Mount Sinai School of medicine in New York:

“I am always embarrassed when I have to tell patients that our treatment guidelines were written by a panel filled with people who stood to gain financially from their decisions. The UK certainly appears to be no different to that of the United States. The truth is for most people at low risk of cardiovascular disease a statin will give them diabetes as often as it will prevent a non fatal heart attack—and they won’t live any longer taking the pill. That’s not what patients are looking for.”
‘There is opposition to the proposed changes to the guidelines from within the medical profession. Apparently, the British Medical Association General Practitioners Committee, has recently decided that: ‘[it] will request that NICE refrain from recommending a reduction to the current treatment threshold for primary prevention of cardiovascular disease with statin therapy, unless this is supported by evidence derived from complete public disclosure of all clinical trials’ data’.

Sadly, our Canadian medical professionals do not seem able or willing to have an independent evaluation of statins.

It was finally admitted about 2 months ago that the centre for the evidence of statins in Oxford UK had never put in the public domain all the results for independent scrutiny.   In other words all the data, claimed by the marketing by Big Pharma, was from trials conducted and paid for by themselves and in which they have controlled the data and its conclusions.  Once independent scientists can see the data they may come to the conclusion that the claims are false and the side effects seriously life threatening as is beginning to emerge in Europe.   It has already been admitted that those patients prone to side effects have been screened out participating in trials and in others the bar of what is a side effect has been set so high it has the same result.   I noted that the placebo effect and the side effect percentages in many of the industry funded trials show the same number – a sure sign numerical evidence has been manipulated.

Side effects:  We know at the current time the major evidenced side effects are:

Myalgia – fatigue, muscle aches and pains ; Diabetes: Brian fog & depression; Liver dysfunction: Interstitial lung disease and possibly increased heart risk.

So for a so called wonderful drug you would reasonably expect to see that the incidence of heart disease and death to be reduced.   The short answer is that it has not. I do not for one moment dispute the likelihood that the drug may have extended life in myocardial cases but that is not the same thing as preventing heart disease or reducing mortality.  A study in Sweden indicated that the use of statins did not in fact reduce acutemyocardial infarction ( heart attacks)Ref: Nilsson S et al. Journal of negative results in biomedicine 2011; 10:6 Kraft et al.

If we look at our Canadian stats on heart disease we see that in 2000 there were 76,046 deaths.  In 2008 there were 69,648 deaths. A differential of some 6,000 deaths given the numerous causes of heart related deaths.  I do not think that statins have had any impact furthermore this clearly shows there is very little value for the billions spent on this drug.   For example,  let us look at smoking which is a cause of heart disease.  It is believed that about 30% of cardiac deaths are due to smoking.  While smoking is declining both obesity and diabetes rates are climbing and both are considered causes of cardiac mortality.  ( Heart & Stroke Foundation & Stats Canada ) When these factors are considered there is no evidence to support claims that statins reduce mortality.   Given they ( statins ) are known to cause diabetes it might be argued they increase cardiac mortality. Prescribing a statin in patients who smoke, are obese, do not exercise is not going to prevent any heart disease as it does not change the physiological results of aberrant behaviour.

All my patients are recommended to take a supplemental CoQ10 if they are taking a statin for the simple reason that statins works by affecting this key enzyme in the body.  Statins reduce cholesterol by inhibiting an enzyme in the liver known as ‘HMG-CoA reductase’. This enzyme ‘drives’ cholesterol production but it also facilitates the production of a substance known as ‘coenzyme Q10’ – an essential in the production of what is known as ‘adenosine triphosphate’ (ATP) – the most basic unit of energy ‘fuel’ in the body. Giving statins to people does have the capacity to lower levels of CoQ10 in the body .

Depletion of CoQ10 is thought to be a major reason for why statins can reduce energy production (and therefore provoke fatigue) in muscles. The heart is the biggest muscle in the body, and depleting it of CoQ10 may be hazardous for cardiac health. Specifically, it may weaken the heart and lead to ‘heart failure’. Researchers have noted the ability for statins to induce CoQ10 depletion in both humans and animals. Passi S, et al. Statins lower plasma and lymphocyte ubiquinol/ubiquinone without affecting other antioxidants and PUFA. Biofactors 2003;18(1-4):113-24.  2.    Langsjoen PH, et al. The clinical use of HMG CoA-reductase inhibitors and the associated depletion of coenzyme Q10. A review of animal and human publications. Biofactors 2003;18(1-4):101-11

Modification of behaviour specifically, diet and exercise, moderate alcohol and no smoking has far bigger effect on cardiac health so Canadians go and enjoy the summer with lots of veggies and exercise!

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