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Ischemic Cardiovascular Disease (CVD)

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Statins Don't Save Lives. Pharmaceutical companies report misleading risk reduction percentages

$tatins Don't Save Lives

Statins supposedly prevent cardiovascular disease (CVD).    Statin drugs, such as  Pfizer's Lipitor® (Atorvastatin calcium), Merk's Zocor® (Simvastatin), AstraZeneca's Crestor® (Rosuvastatin calcium), Pravachol® and Mevacor® are now taken by about 43 million (2019) adults in the U.S. for the purpose of lowering blood cholesterol levels (by inhibiting an enzyme required for a rate-limiting step in the liver's cholesterol production).  They are taken as an attempt to prevent   "cardiac events", such as heart attack or stroke, associated with problems seen in ischaemic cardiovascular disease (CVD), such as coronary heart disease, arrythmia, high blood pressure.

Pharmaceutical companies report misleading RELATIVE, not ABSOLUTE (REAL) risk reduction percentages

For example: Based on a specific trial involving over 10,000 people, Lipitor™ (atorvastatin) manufacturers claim a 36% RELATIVE risk reduction in heart attacks for people with risk factors for heart disease. However, this 36% figure does not factor in the number of people in the trial. 1% of people taking atorvastatin had heart attacks compared to ~3% not taking atorvastatin  --- their calculation ( (3.1-2.0) / 3.1  x  100 = 35.4%) is therefore the RELATIVE risk reduction of ~36%.   The REAL risk reduction is only ~1% (3.1% compared to 2% ) - 1 out of a 100 people taking atorvastatin will be spared a heart attack. i.e. pretty insignificant! For more on this chacanery and to see some "real" risk reductions of taking statins:

Pharmaceutical companies report misleading RELATIVE, not ABSOLUTE (REAL) risk reduction percentages

 

Statins DO significantly reduce cholesterol

However, it doesn't follow that lowering cholesterol significantly decreases the risk of heart attacks or strokes:

•   Multiple studies show that the cholesterol /heart disease connection is a myth.   E.g. the large and ongoing Framington, Massachusetts population study found virtually no connection in CHD events with cholesterol levels in the 205-294 mg/dl range. Even extremely high (up to ~1200mg/dl) levels demonstrated trivial differences in CHD events. (Castelli, 1992; Smith & Pickney, 1991)

•   80% of people who develop CVD have the same blood cholesterol values as those who do not develop CVD or incur a heart attack.

High cholesterol does NOT cause ischaemic CVD, such as heart attacks and strokes

Statins have an anti-inflammatory effect.   Statins minimally protect people from heart attacks /stroke regardless of whether or not they have high levels of blood cholesterol or any other risk factors for that matter.    i.e. the statins are having effects other than lowering cholesterol --- in particular:

•   Statins increase inflammation-controlling nitric oxide (NO) production in the vessel wall.   Free radicals uncontrolled by sufficient antioxidants can diminish NO production, leading to atherosclerosis. Decreasing inflammation lowers the risk of heart attack and stroke.

But . . . there are much better, natural ways than taking statin drugs to lower inflammation, without the multitude of undesirable side-effects.

Serious side-effects of statin drugs

How to treat chronic inflammation

For most people - Statins do NOT much reduce risk of heart attacks, strokes or mortality

The effect of taking statins depends on who is taking them . . .

taking statins can benefit those with familial hypercholesterolemia (FH) 

Individuals born with  familial hypercholesterolemia (FH) , a genetic disorder, are less responsive to the body's usual measures of normalizing cholesterol.  This group represents a minute fraction of those taking statins.

statins as a SECONDARY prevention reduce risk of a major coronary event (e.g. heart attack or stroke), but minimally reduce risk of death

Statin drugs were originally prescribed for secondary prevention.  i.e. for those who already had established heart disease.

Real risk reductions of taking statins after either or both of angina or heart attack  (Scandinavian 4S study, 1994.   4444 patients, median follow-up 1.9 years) :

Major coronary events reduced by 9%.   622 out of 2223 patients (28%) in the placebo group and 431 out of 2221 (19%) in the simvastatin group had one or more major coronary events.  A REAL risk reduction of 9%.

Life expectation minimally increased.   Coronary deaths: 189 out of 2223 (8.5%) in the placebo group and 111 out of 2221 (5%) in the simvastatin group a REAL risk reduction of 3.5%;  while noncardiovascular causes accounted for 49 out of 2223 (2.2%) and 46 out of 2221 (2.1%) deaths --- a REAL risk reduction of 0.1%. (i.e. it saved one person out of a 1000 dying from other than cardiovascular causes). Study reported the 6-year probabilities of survival in the placebo and simvastatin groups at 87.6% and 91.3%, respectively. Again, not much between them!  

LDL cholesterol reduced.    Patients taking Simvastatin had a 50% reduction in LDL cholesterol.

Real risk reductions of taking statins after either a ischemic stroke or TIA (brief episode of neurological function caused by loss of blood flow in the brain, spinal cord or retina, without tissue death).  Meta-analysis examined 9 trials and 10741 patients with median follow-up period 2.5 years. (Tramacere et al, 2019)

Ischemic stroke reduced 1.6%

Ischemic stroke or TIA  reduced 4.2%

Cardiovascular event reduced 5.4%.   A cardiovascular event defined as any sudden death, fatal or non-fatal acute coronary syndrome, stroke, intracranial hemorrhage, or pulmonary embolism; and rhabdomyolysis, myalgia, or rise in creatine kinase (CK). 

All-cause mortality not affected

 

statins As a PRIMARY prevention do not significantly reduce the risk of a heart attack /stroke or extend life

This chart shows the results of a meta-analysis of eight large worldwide trials (24,647 subjects WITHOUT established cardiovascular disease, average 73 years old, typically with a few risk factors for heart disease, such as high LDL, smoker, obesity, high blood pressure) comparing control groups to those of treatment groups lowering their cholesterol using statins (Savarese G et al, 2013)

•   Lowering cholesterol minimally reduced cardiac "events" and did not reduce risk of death.   The people lowering their total cholesterol (particularly LDL cholesterol) levels, showed an average 39.4% RELATIVE risk reduction in number of heart attacks and 24.8%  in strokes compared to the control groups. Sounds positive doesn't it? ---until you realize that:

(a) MI occurred in 2.7% of subjects allocated to statins compared with 3.9% of those taking placebo during a mean follow-up of 3.5 years. i.e. the REAL risk reduction was a mere 1.2%.  i.e. Of 1000 people treated, only 12 would NOT have a heart attack.

 (b) Stroke was reported in 2.1%  subjects randomized to statins compared with 2.8% in placebo during a mean follow-up of 3.5 years. i.e. the REAL risk reduction was a mere 0.7%.   i.e. Of 1000 people treated, only 7 would NOT have a stroke.

(c) The risk of all-cause death and CV death were NOT significantly reduced.

•   65-75% of patients who lower their LDL cholesterol with a cholesterol-lowering therapy continue to have cardiovascular events.

Flawed “JUPITER Study” is the major supporting study in the push for statin use as PRIMARY prevention against heart attack / stroke

(JUPITER: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin)

Headline: “Rosuvastatin can slash risk of heart attack by 54% and stroke by 48%”

"Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein".  This 2006 study published in the New England J. of Medicine in 2008 (Ridker et al. 2008), supposedly determined that statin drugs could lower heart attack risk 54%, risk of stroke by 48%, and risk of needing angioplasty or bypass surgery by 46%, and the risk of death from all causes by 20%. It was taken at face value, despite the fact that funding for this study came from Astra-Zeneca, the maker of Crestor®.

The JUPITER trial promoted statin use as preventive medicine against a FIRST time heart attack or stroke (i.e. primary prevention) adding to its original prescription for the prevention of a SECOND heart attack or stroke (i.e. secondary prevention), and so expanding the market to those with an inflammatory risk factor (elevated C-Reactive protein) for CVD.    The study claimed that statins could significantly prevent people with elevated C-Reactive protein, but otherwise healthy without a history of cardiovascular disease (CVD) or high levels of low density lipoprotein (LDL) cholesterol)  from having a heart attack or stroke.

Lies, Damn Lies, Statistics and the JUPITER study:

In the JUPITER study there were 68 heart attacks in the placebo group and 31 heart attacks in the statin drug treatment group.   A RELATIVE risk reduction of 54%. There were 64 strokes in the placebo group, compared to 33 strokes in the treatment group, a relative risk reduction of 48%. Sounds good, doesn't it? However, here is the reality:

In a drug treatment group of 8,901 participants, the heart attack risk was reduced from a very low 0.76% to 0.35% and the risk of stroke from 0.72% to 0.37%. In effect, if you treat 300 people with expensive and dangerous drugs you might save one life. Under the best possible scenario, the real risk reduction was under 0.5%.

In perspective, consuming a handful of raw mixed nuts has a much higher real risk reduction!

Pharmaceutical companies report misleading RELATIVE, not ABSOLUTE (REAL) risk reduction percentages

Three articles were published in the Archives of Internal Medicine in June 2010, refuting the industry-funded JUPITER study claims

(1) An independent assessment of the same statistics in 2010 entitled “Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy. A Critical Reappraisal “  found that “the JUPITER Study” was severely flawed. This recent analysis did a careful and independent review of both results and methods used in the Jupiter Study and reported that the “trial was flawed”. In an unprecedented attack on the study they stated that “The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study.”And concluded:

“The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.”  (de Lorgeril et al, 2010)

(2)  Meta-analysis of 11 randomized controlled trials (Ray KK et al, 2010). involving a combined total of 65,229 participants with a high-risk for heart disease and followed for approximately 244,000 person-years.    No evidence was found to back up the JUPITER trial claim that statins can statistically reduce your risk of death when used as primary prevention against heart disease i.e. they don't save lives even if you do have elevated risk factors. (Ray, K.K. et al, 2010).

(3) Cholesterol-lowering therapy for primary prevention: still much we don't know. Dr. Lee Green of U. of Michigan Medical school points out that billions of revenue dollars were at stake for the study sponsor in the JUPITER trial, as well as potentially millions of dollars in royalties for the principal investigator.  (Green LA, 2010)  

$tatins are “pushed” mainly to make mega-profits for the drug companies

In 2008, Pfizer made $12.4 billion in sales of Lipitor®  –   the top-selling branded pharmaceutical in the world

Recommendations are an “Inside Job”.   A  panel of “experts” (8 out of 9 on the payroll of statin drug manufacturers) recommended lowering blood cholesterol of high-risk heart disease patients to levels so low, they are only attainable by using their employers' statin drugs.

How many more studies do we need to show that statins don't work?

Studies by the Medical Research Council dating back to the late 1980s.  

•   Researchers found that of 1,000 men ranging in age from 35 to 64 who received treatment for mild hypertension over five years, there were six fewer strokes and two fewer cardiovascular events than would be expected. The REAL reduction was 0.9%.  (Medical Research Council Working Party, 1985;  Miall & Greenberg, 1987).

  5 year study with 1000 middle-aged men having high cholesterol but no previous history of heart attack touted a 22% drop (relative risk, not real risk) in mortality.   It resulted in 7 fewer deaths from cardiovascular causes, and 2 fewer deaths from other causes than would be expected. The real risk reduction was therefore a mere 0.9%. (9 out of a 1000 men ) The research was sponsored by Bristol-Myers Squibb Pharmaceutical (West of Scotland Coronary Prevention Study). (Shepherd et al, 1996).

The Heart Protection Study in the United Kingdom.    20,000+ participants aged 40 to 80 years with high risk of cardiovascular disease but average-to-low levels of total cholesterol and LDL cholesterol were treated with 40mg daily of simvastatin (Zocor®). 577 out of 10,269 people on statins and 701 out of 10,267 not treated died from a heart attack --- a 25% relative risk reduction over five years, but a REAL risk reduction of only 1.7%. (Heart Protection Study Collaborative Group, 2002).

A study of 90,056 participants combining 14 randomised trials looked at the best outcome for people who had pre-existing conditions: 47% had pre-existing chronic heart disease, 21% had a history of diabetes and 55% a history of hypertension. The death rate was 8.5% among the statin group compared to 9.7% in the control group. This is a 1.2% REAL risk reduction.  (Baigent C et al, 2005)

A 2008 study reported in the British Medical Journal - a meta-analysis of 10 randomized clinical trials of about 70,000 people followed for an average of four years. In these trials, people with risk factors for cardiovascular disease but no history of existing disease were randomized to receive statins or no treatment. The relative risk reduction was 12% for total mortality, 30% for coronary event and 19% for a cerebrovascular event (stroke). However, the real risk reduction was 0.6%, 1.3% and 0.4% respectively. The actual number needed to treat to save one life was 167. Despite this insignificant outcome, the authors of the study concluded, “In patients without established cardiovascular disease but with cardiovascular risk factors, statin use was associated with significantly improved survival and large reductions in the risk of major cardiovascular events.”  The authors had significant associations with the drug companies. (Capewell, 2008).

References

Baigent C et al (2005 Oct 8) Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 366(9493):1267-78. Epub 2005 Sep 27. LInk

Capewell, S. (2008). "Will screening individuals at high risk of cardiovascular events deliver large benefits? No." British Medical Journal 337: a1395.

Castelli, William (July 1992), “Concerning the Possibility of a Nat. . .” Archives of Internal Medicine, 152: (7): 1371-1372

de Lorgeril M et al (2010), Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal, Laboratoire Coeur and Nutrition, Faculty of Medicine, Université Joseph Fourier and Centre National de Recherche Scientifique, Grenoble, France, Arch Intern Med. 2010 Jun 28;170(12):1032-6   Link

Green LA (2010 Jun 28) Cholesterol-lowering therapy for primary prevention: still much we don't know, Arch Intern Med;170(12):1007-8; Link

Heart Protection Study Collaborative Group (2002). "MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial." Lancet 360: 7-22.

Medical Research Council Working Party (1985). "MRC trial of treatment of mild hypertension: principal results." British Medical Journal 291: 97-104.

Miall, W.E. and G. Greenberg (1987). Mild Hypertension: Is There Pressure to Treat? An account of the MRC trial. New York, Cambridge University Press.

Ray KK, et al (2010) Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants, Department of Public Health and Primary Care, University of Cambridge, Cambridge, England, Arch Intern Med. 2010 Jun 28;170(12):1024-31  Link

Ridker, P.M., E. Danielson, et al. (2008). "Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein." New England Journal of Medicine 359(21): 2195-2207. Link to the JUPITER trial

Ridker PM; Jupiter Study, Group (Nov. 2003). "Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: rationale and design of the JUPITER trial" Circulation. 108 (19): 2292–7  Link

Savarese G et al (2013 Dec 3) Benefits of statins in elderly subjects without established cardiovascular disease: a meta-analysis. J Am Coll Cardiol;62(22):2090-9. doi: 10.1016/j.jacc.2013.07.069. Epub 2013 Aug 28. Link

Scandinavian 4S study (1994 Nov 19) Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) Lancet. 344(8934):1383-9. Link

Shepherd J et al. (1996). "Prevention of coronary heart disease with Pravastatin in men with hypercholesterolemia." New England Journal of Medicine 333: 1301-1307.

Smith, R. and E.R. Pickney (1991) Diet, Blood, Cholesterol and Coronary Heart Disease: A Critical Review of the Literature, Vol 2, Vector Enterprises, Sherman Oaks, CA

Tramacere, I et al (2019)  Comparison of statins for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysis, BMC Medicine 17, Article number:67   Link

 

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