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HEART MEDICATIONS & TREATMENTS

Why Statins are not worth their side effects


For confirmation from journal articles on primary role of infective agent enter into http://scholar.google.com/ terms such as bacteria + atherosclerosis or go to http://healthfully.org/rl/id8.html and id9  for collection of articles

For confirmation of cholesterol myth enter into http://scholar.google.com/ or http://www.amazon.com/ cholesterol myth, or go to http://healthfully.org/rl/id5.html for collection of journal articles.

Statins a 3 Page Critical Review   (update 7/9/15) http://healthfully.org/rc/id6.html 


It is essential for you to understand how pharma (pharmaceutical industry) distorts, and controls medical information, and guidelines, thus read Market Science and Misinformation,   side effect, & Marcia Angell’s book.  Marketing pitch for the statins is based on high Total Cholesterol (TC) and LDL causing heart attacks, strokes and, CardioVascular Disease (CVD); but CVD is caused by bacterial and viruses within the artery wall (tunica media that cause atherosclerosis (AS), thus lowering cholesterol doesn’t work--see Cholesterol Myth.  Claims of saving lives are based on tobacco science, as too are the guidelines[1].  As the material below demonstrates, it all is upside down and worse.  The best-selling drug of all times is atorvastatin, marketed as Lipitor by Pfizer (US sales $12.4 billion in 2008, and world-wide total sales of $131 billion by 2007).  With 50% of the men and 36% of the women age 65 to 74 taking statins (CDC/NCHS, Health, US, 2010); their human costs is incredible including , while better alternatives[2] are shown harmful by pharma’s tobacco science.   The cholesterol myth and effective prevention  get little space in the corp. media.—watch YouTube documentaries.


 


Statins discovery and approval casts doubts.  In the early 1970s an extract from a fungus was shown reduce serum cholesterol, but the Japanese research stopped because of animal toxicity & cancer.  Using a similar extract Merck in 1978 developed Mevacor (lavostatin).  This “’Statin produced significant toxicity at high doses in a variety of animal species” (ibid 520).  Animal studies showed it caused cancer (given the 20-year latency in humans, still a grave concern).  Merck tested low-dose Mevacor for homozygous familial hypercholesterolemia.  The FDA gave approval for this rare condition.  Once approved--as is the norm--the population base was expanded based on “marketing science”.  Because statins lower TC 30%, they were pushed as the only effective treatment for CVD.  But weak epidemiological association of elevated TC with CVD doesn’t demonstrate cause.   With in-house studies Merck and the manufacturers of the 9 me-too statins sold the world on “safe-and-effective”.  In Braunwald, Heart Disease, 8th Ed. P 2286: “safe, effective, and well-tolerated pharmacologic agents that have greatly expanded the therapeutic armamentarium available to the physician to treat disorders of lipid metabolism.”  But in Braunwald, p 1085 table, 3 of 4 listed studies didn’t support effective.  Merck’s JUPITER Study, 2008, is used to push primary prevention, but has major internal inconsistency:  the cooked results “do not support primary prevent of CVD”.  Moreover, “statin therapy and top athletics seem to be almost incompatible,”73% dropped out.  Statins don’t extend life and their side effects are grossly under-reported.  Because statins don’t treat the causes of CVD, they are ineffective; thus there is a chorus of marginalized critics.


18 NEGATIVE EFFECTS:  One, ED, it lowers testosterone , and  nitrous oxide thus causes ED; a similar effect upon women for the steroids are synthesized from cholesterol. Two, COX-2 inhibitor, just like Vioxx, which increased heart attacks (MIs) over 300%[3].  The American Heart Association warns: “accumulated evidence that non-steroidal, anti-inflammatory drugs [COX inhibitors], with the exception of aspirin, increase risk for heart attack and stroke”--promote atherogenesis. Three, blocks production of Q10, which enters LDL and inhibits oxidative damage that causes atherogenesis, and.  Four, Plaque instability:  “Vulnerability of plaques to rup­ture and thrombosis is of greater clinical relevance than the degree of stenosis they cause” (Corti et al., 2003).  Statins affect plaque stability in a variety of ways.  The meta-loproteinases degrade extra-cellular matrix components and thus “weaken the fibrous cap and destabilize the lesions” -- Goodman and Gilman pharmacology, 11th Ed, p 950.  Rupture of plaque causes over 80% of MIs.  Statins inhibit secretion MMP-1, 3, & 9 from SMC, and microphages make plaque less stable.   Five, reduction in ATP:  Q10 is needed for the conversion of APD to ATP (adenosine-5-triphosphate), the source of energy for muscles contraction.  “ATP is often called the ‘molecular unit of currency of intracellular energy transfer including muscle contraction and for chemical reactions.  ATP transports chemical energy within cells for metabolism--Wikipedia.  A reduction of 40% in CoQ10 is accepted.[4]  Six, The heart muscle under stress needs more ATP, not less.  This is why pharma excludes the elderly and those with coronary heart failure (CHF) from trials.   Thus, “the mean age of ME/CFS patients dying from CHF are 2.5 years younger than the control group.”  CHF death rate  has tripled since 1989.  In a review of statins on depletion of Q10 concludes:  “As the potency of statin drugs increases and as the target LDL cholesterol level decreases, the severity of Q10 depletion increases and heart-muscle function declines. This tragic scenario may very well be prevented by using supplemental Q10 with all HMG CoA reductase inhibitors [statins]” and, and. Thus “Lower cholesterol, poorer outcome in CHF patients.”  Pharma ignores Q10 side effect.  Seven, All Statins inhibit the rate controlling enzyme HMGCR of the mevalonate pathway.  This pathway generates a range of other products in addition to cholesterol, including coenzyme Q10, heme-A, [dolichol], the production of dimethylallyl prophosphate (DMAP),  &  isopentenyl pyrophosphate (IPP), which serve as the basis for the biosynthesis of molecules used in processes as diverse  as terpenoid synthesis, protein prenylation and isoprenylated proteins  which have pivotal roles in cell biology and human physiology and potential relevance to benefits as well as risks of statins.  Drugs, such as the statins, stop the production of mevalonate by inhibiting HMG-CoA reductaseWiki.  “The Mevalonate pathway is important for, cell membrane maintenance,  hormones, protein anchoring, and N-glycosylation.  It is also a part of steroid biosynthesisWiki.  Dolichols are isoprenoids  synthesized from mevalonate. They are vital to the process of Glycoprotein formation in the endoplasmic reticulum of cells. In this capacity it is critical to the formation of the Glycoproteins involved in neuro-peptides, cell identification, cell messaging and Immune defense.  Reduced bioavailability of dolichols can affect every cellular process in the bodyWiki.  And this is only a partial list.  Eight, Cholesterol is essential for life.  “It is the precursor for the biosynthesis of steroid hormones, bile acids, vitamin D, and is an essential component of cell membranes for proper permeability and fluidity.  Effects include pancreatic and hepatic dysfunction, ED, diabetes[5], muscle weakness and myopathy (muscle disease). The myelin is a cholesterol base coating around nerve cells[6] (Wiki).  Nine, Cognitive, the reduction Q10 & cholesterol for the myelin sheath causes cognitive decline--especially in the elderly where it often leads to an incorrect diagnosis of Alzheimer’s disease and of neuropathy.  Ten, Causes Parkinson’s  and Alzheimer’s diseases.  These conditions are associated with low level of cholesterol—at Uffe p 56.   Eleven Causes cancer a confirmation of earlier animal studies—summary of cancers, and.  Twelve  Stimulates atherosclerosis and heart disease by blocking the vital CoQ10, heme A, vitamin K2 (the cofactor for matrix Gla-protein activation) and biosynthesis of selenium containing proteins, one of which is vital glutathione peroxidaseat 2015.  This article states that “statins stimulate atherosclerosis and heart failure”, and then provides the mechanisms.  Thirteen Causes Interstitial lung disease is similar to emphysema in that it is a progressive condition that affects alveolar epithelium and other tissues.  Of FDA reported side effects, it is 1/40th.  Fourteen, Causes cancer in animal studies, and thus in humans, at.  Fifteen, Side effects account for the poor compliance in the elderly (75% stop within  2 years).   Poor compliance also occurs with elite athletes (see 1st pg).  Sixteen treats the wrong cause, cholesterol doesn’t cause ischemic events or  atherosclerosis but rather infective agents (and) living in the tunica intima; thus statins are ineffective.  Three out of 4 major studies of secondary prevention (ALL-HAT, ASCOT, & PROSPER) failed to find life extension from statins (Table 42-78, Braunwald’s Supra, p 1085).  This table stands in opposition to the “safe & effective” claim (p 2286), which is pharma’s mantra, a mantra supported by their marketing studies and guidelines. Junk science is the norm (p 3) on TNT trial. Seventeen, Primary prevention of high risk no benefit huge meta-study found, in JAMA.  Eighteen, drug interaction with serious side effects are common, considering that over half of senior in their 6th decade have taken statins, and seniors average age 72 average 6 drugs according to a hospital emergency admission study (polypharmacy).  


THREE POSITIVE EFFECTS:  1) Anti-inflammatory effect:  but because of effect upon prostaglandins statins like the NSAIDs doesn’t inhibit atherogenesis inflammatory process—see Vioxx, and.  2) Statin reduces the risk for thrombosis by affecting clotting, just like aspirin.  But rather than promote the sales of over-the-counter NSAID, pharma pitches lower TC.  3) For the rare familial hyperlipidemia extends life modestly at best—Prof. Ravnskov, Ignore the Awkward, chap. 3.


On statins:  Since “cholesterol synthesis occurs mostly at night” (Wiki), TC should be treated at night with short half-life[7] & low dose:  Zocor 2 hrs, Mevacor 1.4 hrs, Pravachol 1.75 hrs, and niacin 35 min.  Avoid Lipitor 14 hrs, Crestor 19 hours. 


Sorting it out, RECOMMENDATIONS:  Atherogenesis is caused pathogens within the artery walls.  This initiates  an inflammatory immune response by macrophages.  LDL which has an immune response is actively transported into the artery walls where it contents cholesterol from part of the resultant plaque.  Because of this transport process, lowering LDL doesn’t affect the formation of plaque, thus statins don’t stop plaque formation or remove it from within artery walls (see illustration).  The 32% drop in deaths from heart attacks and strokes (1960 to 1992) occurred prior to statins.  With statins’ wide use, mortality rate has remained constant.  Mevacor was approved in 1987 with only 60,000 taking it by 1990.  Reduced death rate was from less cigarettes and better treatment.  Statins reduce quality of life for the elderly: a large Canadian study had 75% dropout by 2 years, and 80% in a NJ study.  Very common and under reported side effects are:  fatigue, muscle weakness & cramps, mental confusion, pancreatic and liver dysfunction, diabetes, indigestion, cognitive decline, ED, & lower libido, especially for the elderly.  Lowering TC with statins doesn’t affect the young unstable plaque that cause 85% MIs because pathogens are the cause of the plaque formation.  .  What to do:  Don’t take a statin because they do not reduce mortality; they aren’t worth their side effects & expense.  Lifestyle changes of low carbohydrate-sugar diet lowers damage to endothelial cells on the artery walls.  Damage is caused mainly by glycation by fructose (7.5 times the rate of glucose).   Avoid carbon monoxide (cigarettes main source) which exacerbates the damage.  Endothelial cells block the migration of pathogens.  Saturated and monounsaturated fats are the best source of energy.  Everyone should take the antioxidants ascorbic acid and Q10, prevent oxidative damage.  Take 325 mg aspirin[8] with meals for its anti-inflammatory effect that prevents CVD; and aspirin prevents blood clots thus lowering ischemic events, etc5.  Low dose aspirin is ineffective because of tolerance after 1 year.  Take the natural estrogen (estradiol) & progesterone at menopause.   Estrogen[9] lowers risk of CVD 50%, osteoporosis and much more.  For elderly men testosterone lowers risk & increases survival from an MI.  Pharma attacks hormones & aspirin because they work.  Read Marking Science, be skeptical of medical “wisdom.”   If you still want to lower TC then take 250 mg slow release niacin or inositol hexanicotinate  at night, when it is effective.  Insulin produced following meals blocks the lipid lowering effect of niacin inositol & statins.  High dose during the day is a pharma ploy to reduce the use of niacin. 


JK has exercised vigorously since 1975; 325 mg twice daily aspirin since 1992; testosterone high dose 2003; low-sugar low carb diet 2014, 300 mg CoQ10 2012, and vitamin C 1000 mg (as calcium ascorbate) 2014.  Results:  JK is in 7th decade, excellent muscle tone and strength, no joint pain, blood pressure averages 125/75, BMI 23, and total cholesterol 165.  Pharma  has turned  hypertension, and cholesterol into medical conditions, and watch documentaries on YouTube.   




[1] New guidelines (3/2014) based on a 10 year 7.5% risk for MI would put 87% of men and & 56% of women age 60-75 on statins.

[2] See the 8-page paper ”On Lifestyle Diet and Drugs, or 2-page summation. Two studies have shown using raw data that positive bias is 32%.for pharma’s clinical trials. Pharma’s business model drives them to marketing patented drugs for chronic conditions, most of which are ineffective.  

[3] A reasonable assessment of total early deaths from the selective COX-2 inhibitors in the US would be over 200,000; and a much greater number for the non-selective COX inhibitors, the NSAIDs—but for aspirin.  Celebrex is still on the market, and though warnings about all COX inhibitors warning that they promote CVD, the oft-heard sales message prevails. 

[4] After 3 months treatment of healthy patients with a poor TC using pravastatin or simvastatin, the total cholesterol and CoQ10 (Q10) were lowered 40%, when compared to the placebo group.  “A diminution of Q10 availability may be the cause of membrane alteration with consequent cellular damage”Journal of clinical Pharmacology.  This finding is supported in other studies and widely accepted—summary article.  

[5] 9% increase in risk of developing diabetes over 4 years, meta study Lancet 2010 based on pharma trials--undoubtedly under-reported. 

[6]  The 2nd cause for neuropathy, the first low Q10.  The two are additive.

[7]  Half-life (t) the time that it takes for the concentration in blood plasma of a substance to reach one-half of its initial measured level “(Wiki). 

[8]  Aspirin very significant risk reduction of most major cancers and Alzheimer’s disease, plus it reduces mortality from stage I, II, III cancer over 40%, and by 4 mechanism atherogenesis.  The long-term risk for stomach bleeding is about 4%; comparable to other NSAIDs and many other drugs.  Pharma’s attack with FDAs help is market driven.  Low does not have an anti-inflammatory effect and tolerance develops to its anti-platelet effect.

[9] For many benefits of natural HRT, and testosterone for men; and don’t believe the marketing science about hormones. 



^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^Non-technical summation                                     

Statins and cholesterol:  Cardiovascular disease (CVD) results from pathogens within the artery walls that cause an inflammatory response by macrophages that results in the formation of plaque.  The risk of infectious bacteria and viruses colonizing the artery walls is increased by artery endothelial dysfunction (cells which line the artery walls and thereby control the entry into the underlying tissue).   Major causal factors for endothelial dysfunction is a high blood sugar (especially fructose which is 7.5 more reactive than glucose) and high insulin level (insulin resistance).  Carbs through glucose increase insulin, and table sugar is a disaccharide consisting of fructose and glucose.  Thus low carb low sugar diet is the first line of prevention. Carbon monoxide--main source smoking—can significantly exacerbate endothelial dysfunction.  Both are reactive chemicals which damage the endothelial cells.   Macrophages are a type of white blood cell that scavenges damage cells and promote healing.  A lower level of cholesterol doesn’t prevent the active transport of LDL as part of the immune-healing response; thus statins do not affect the active transport process.  A large body of evidence has demonstrated that cholesterol and triglycerides are mere bystanders, and that statins though they lower cholesterol do not prevent CVDsee and watch documentaries.  Cholesterol and fats are present because of an immune response that goes on.  Statins are the biggest scam in pharma’s history.  And it made all the worse not only by chasing after causes which don’t protect against CVD, but also because of their affect upon quality of life, which very significantly affect those above the age of 60.  Cholesterol is used to synthesize numerous essential compounds and is part of cell membranes.  Lowering it production—typically 40%--has many common side effects.  Statins also lower the production of CoQ10 by 40%.  CoQ10 has an essential function in the production of ATP, the body’s energy molecule.  Statins for all these reasons should not be taken, especially among the elderly whose production of ATP has significantly dropped with age.     

TERMS:  Primary prevention for those with high cholesterol only.  Secondary prevention for those with pre-existing cardiovascular disease (CV).  Opinion Leader: an authority in a specialty who receives substantial income from pharma.  Cardiovascular Disease (CVD) any disease, whether congenital or acquired, of the heart and blood vessels.  Cholesterol Profile (TC) the lab report listing the various components of cholesterol.  Coronary Heart Disease (CHD) atherosclerotic arterial deposits (atherosclerosis).   Congestive Heart Failure (CHF)/ heart failure (HF) occurs when the heart muscle is unable to maintain adequate circulation of blood in the tissues of the body or to pump out the venous blood returned to it by the venous circulation.  Myocardial Infraction (MI) a heart attack.  HMG-CoA reductase inhibitors (statins).




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