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and 7 years since they postulated that statin benefit might be negated long-term by adverse  non- CVD mortality at CVD risk below 1.3%pa.

It is almost 40 years since as a junior medical registrar I was first advised to take lipid-lowering drugs (clofibrate- just a few years before the cancer link came out),

and  have since then been advised  to take statins .

I have never done so  (for my familial mild-moderate type 2b  lipidemia),  because the evidence has never justified such experimental and long-term unproven synthetics (as with modern antidiabetic and anti-osteoporotic wannabe money spinners) in search of $billions for the western Drug Corporations and their investors and lobbyists.  

   Lately,  despite the massive statin trials, the last  statin  metanalysis (2003 from University Slovenia) again failed to show any reduction in non-CVD cardiovascular  disease mortality;

and since CVD is the major cause of death and disability  ONLY in those who already have such disease, statins remain indicated only in secondary prevention -as was shown in the last two major trials published, in 2002 ( ALLHAT-LLT  and WESCOPS), now confirmed in the Japanese MEGA study  (2006) of low dose statin, which (in primary prevention in a slim population)  showed similar barely significant 1/3 CVD mortality benefit- significant reduction only in myocardial infarction -  but no significant other  cardiovascular or non-vascular benefit even after a mean of 5.3years, 41 000 patient-years.   

 Last month  Theo Jacobson from Emory University in Atlanta GA  commented that myalgia is the leading reason why patients abandon statins. 

 In 2000 he already questioned the marketing hype for statins  that “the lower the cholesterol level is driven, the better” . 

The growing scandal is the increasing marketing  pressure  by Big Pharma lobbyists (including  some Regulator  staff) to promote prescription and even over-the-counter use of statins to achieve ever-lower low-density lipoprotein levels even in the absence of any vascular disease or CVD risks- including the farcical inclusion of statin in a PolyPill (led by Ward and Law and the BMJ in  UK). .

 Last year Kilmer McCully himself  (the father of the homocysteine hypothesis in CVD 1969) points out that the dramatic fall in CVD mortality  since  it’s USA peak in 1955 correlates well with voluntary and mandatory fortification with B6, B9 and B12 (let alone niacin) .

We may also note that  falling  premature CVD mortality coincides with

• the increasing use of metformin the past decades  (which lowers all-cause morbidity and mortality, and new diabetes, by 1/3,  and overweight by about 8%); for both treatment and prevention of type 2 diabetes, overweight, lipidemia and polycystic ovary syndrome.;
• and with increasing use of appropriate sex hormone replacement for aging men and women (which lowers all-cause morbidity and mortality by 1/3); .
•  and with targeting of lower blood pressure levels even in the elderly hypertensives since the SHEP trial (1985).   
•  and with growing intake of supplementary fish oil ((which lowers all-cause morbidity and mortality by  almost 1/2);  
•   and  of other insulin sensitizer- Nitrric oxide - antioxidant -metabolic promoters  (like vitamins A,  B1, B3,B7, C, D, E, K, calmag, zinc, chromium and other trace elements), and the dozens of our other  crucial  biologicals that decline with aging and illness, (like coQ10, n-acetyl cysteine, arginine, carnitine, carnosine, ribose, chondroglucosamine, lipoic acid, taurine, bioflavinoid, thyroid, melatonin  etc).

And while statins have legion adverse effect from insidious fatigue to myositis and hepatorenal impairment; dermatitis, depression; reducing steroid levels and virility; and lately  producing even lung damage, (unlike the natural supplements listed  that are the best drugs),  they have never been shown to have the slightest benefit on non-CVD pathology, from overweight and insulin resistance - diabetes  to arthritis. Manufacturers and lobbyists have studiously avoided head-on trial comparison with  the natural CVD preventatives  listed above which simutaneously address both the underlying metabolic cause of hypercholesterolemia (insulin resistance and atheroma) and all the other major common degenerative diseases of aging. So the direct highpressure marketing od statins to the public  - without prescription - for other than severe resistant hypercholesterolemia is thus dangerous massive corporate fraud.

So there is every reason why statin use should be severely limited to only  high-risk CVD cases i.e. those with  dangerous homozygous familial hypercholesterolemia resistant to all other  interventions.

see for references:

(more…)

Why is there surprise at the new 4year international study (in NEJM of 3 April 2008 http://content.nejm.org/cgi/content/abstract/358/14/1431 ) that further 26% lowering of average “bad” low density cholesterol LDLC - level (and CRP c-reactive protein) by adding a new designer drug for 2 years to a statin alone makes no further difference to vascular or all-cause outcome? In fact in even this young population there were 46% more cardiovascular CVD events on the statin - ezetimibe combination (10/357 = 1.4%pa) than on simvastatin alone (7/363 = 0.96%pa).

At baseline the subjects at a mean age of 46+- 10yrs (half men) were an average of about 10kg overweight; 28% smoked, only 16.4% were already hypertensive, but 80% already on statins (they had to have had a total cholesterol TC of >5.43mmol/L off lipid-improving drugs – their mean TC off drugs was 10.4mmol). Other than the 5% who had already had heart attack, and perhaps the 2% who were diabetic, why were these average mostly well young people targeted for further cholesterol lowering, when their mean TC was already down to 6.9mmol/L on statin (vs 5.7 on the twin drugs) with HDL 1.2 ? when all they needed to do was lose a few kg fat by sensible eating and exercise, stop smoking and take some safe fat-reducing anti- atheroma antioxidant and insulin-sensitising supplements including fish oil? Why should lowering of blood markers already within the average range give any benefit as opposed to doing harm? According to Sijbrands (BMJ 2001) from Erasmus University http://www.bibalex.org/Supercourse/lecture/lec3191/001.htm, such a cohort of people untreated has a standardized mortality ratio of 1.88- but in this new 2008 Enhance paper, their mortality rate on statin alone was already so low (CVD mortality 0.1%pa) that all-cause mortality was not even mentioned.

So it should be asked why such a trial was undertaken, when there has never been any evidence that drug lowering of mild to moderate TC (ie below 8mmol/L) or LDLC lowers non-CVD morbidity and mortality? – and when there are legion proven supplements that lower morbidity and mortality ? The evidence against cholesterol lowering in those without high CVD risk was already shown over a decade ago by the Sheffield team (Haq 1995), who have consistently stressed that “cholesterol measurement by itself is not a good way to identify those with high coronary risk”, and that there is little advantage (except for anti-cholesterol practitioners and laboratories) in lowering average cholesterol levels unless CVD risk is at least 2% if not 3% a year. The CVD risk of this Enhance trial cohort on statin was only 1% a year.

No statin trial has ever shown that these lipid-lowering drugs drugs lower or even address non-vascular disease or mortality; whereas (except in those at the highest cardiovascular risk) nonvascular degenerative disease is by far the bigger burden in later years. Dr James le Fanu summarised the evidence against universal cholesterol-lowering in mild-to-moderate lipidemia already in The Rise and Fall of Modern Medicine (Abacus UK 1999).

Since according to the lipid-lowering industry, most of us overweight older folk naturally have risky lipid levels to be targeted by zealous drug marketers and prescribers, some British doctors who know better have actually invested heavily in promoting (without evidence of global benefit :risk) a farcial polypill including a statin, an antihypertensive and aspirin for all. http://www.bmj.com/cgi/content/full/326/7404/1419

It is common cause that after 30 years of widespread use, statins do nothing for overweight, insulin resistance, hyperglycemia, other CVD factors, nor for other major degenerative diseases of overweight and aging - infection, osteoporosis, cancer, arthritis, sexual dysfunction - and thus do nothing to lower non-vascular morbidity and mortality. But statins do cause widespread insidious fatigue, myalgia, depression, impotence; and now lung and tendon rupture complications, let alone hepatorenal problems- are being increasingly reported.

By contrast, it is common cause from both trials and observational studies for >30years that APPROPRIATE
1) metformin for overweight/ lipidemia; 2) fish oil; 3) combined hormone replacement; and 4) blend of the other proven >60 supplements (~15 vitamins, ~10 minerals, and the >35 biologicals including herbs), each reduce all-cause morbidity and mortality by one-third to half. Together, the combination is impressively effective in daily practice in the most desperately ill patients already on maximum conventional prescription modern drugs for osteoporosis, arthritis, CVD, type 2 diabetes on insulin with crippling neuropathy etc.

Such is the insidious influence of the global drug industry via Regulators (Elaine Feuer Innocent Casualties: The Fda’s War Against Humanity USA 1996), that we physicians are threatened with prosecution by our own medical defence advisor if we do fair comparative marketing, promote that appropriate well-proven old drugs- the natural micronutrients which drug companies prudently refuse to sponsor to be tested against modern patented prescription drugs - are better for both prevention and treatment of chronic degenerative diseases of aging than the imitator modern wannabe patentable designer drugs that attempt to mimic the original natural drugs- vitamins, minerals, biologicals - evolved and proven over millennia.

We are even threatened with prosecution for using metformin for prevention of diabetes and lipidemia, when it is the only patent drug that has ever been tested in a 20year RCT (Holman ea the UKPDS 1998), and proven to halve all-cause mortality over 5 years in type 2 diabetics, and it halves the incidence of new diabetes in overweight people with metabolic syndrome risks; whereas in trials, sulphonylureas - like all other modern patent designer drugs - had no benefit on all-cause mortality or on decreasing new diabetes incidence in older adults.

Ndb
Refs:

Haq IU, Jackson PR, Ramsay LE ea Royal Hallamshire Hospital, Sheffield, UK Sheffield risk and treatment table for cholesterol lowering for primary prevention of coronary heart disease. Lancet. 1995;346:1467-71 http://www.ncbi.nlm.nih.gov/pubmed/7490996 and Prediction of coronary risk for primary prevention of coronary heart disease: a comparison of methods QJM. 1999 ;92:379-85. http://qjmed.oxfordjournals.org/cgi/content/abstract/92/7/379

J.P. Kastelein ea, for the ENHANCE Investigators http://content.nejm.org/cgi/content/short/NEJMoa0800742 NEJM 3 Feb 2008: 358:1431-1443 Simvastatin with or without Ezetimibe in Familial Hypercholesterolemia

THE HARMFUL (AND LARGELY UNNECESSARY) MARKETTED CHOLESTEROL-LOWERING DRUGS

A new study from Texas University (Riechman SE ea, Statins and dietary and serum cholesterol are associated with increased lean mass following resistance training. J Gerontol A Biol Sci Med Sci. 2007;62:1164-71) shows that the cholesterol-busting statins significantly increase muscle mass. But the authors carefully analyze why this did not translate to increase in muscle strength. In fact many studies show that these drugs cause muscle damage- pain and fatigue, weakness – in up to 25% of users – especially with exercise - perhaps especially where there is pseudohypertrophy, which is probably what Riechman ea saw, muscle swelling from statin-induced damage..

This contrasts with physiological human androgen (testosterone) which cause genuine increase in both lean mass and strength (independent of exercise, and far more so with exercise), whether in bodybuilders or in the frail elderly (Bhasin ea 1996 et seq). Statins predictably cause the reverse- muscle damage pseudohypertrophy associated with significant fall in androgen levels, depression, impotence, lung, liver and kidney damage…

Contrary to the hype of the marketing industry (which funds the Regulators – FDA, Governments, Academics and the vast Disease Industry through “research” grants, taxes, jobs and congresses), there is no good reason to take or prescribe routine statins since evidence does not support their benefit EXCEPT in rare severe hypercholesterolemia. Cholesterol is not the cause of disease, it is a key biological building block – common mild to moderate lipidemia is mostly a manifestation of simple dysmetabolism, mostly insulin resistance from lack of exercise and a few score micronutrients that are safely, easily and cheaply supplemented .

The creation of the non-existent hypercholesterolemia epidemic to sell statins is well described by Dr James le Fanu in The Rise and Fall of Modern Medicine: Abacus, London, 1999;
and was mimicked a decade later by Pfizer in fabricating a pandemic of impotence to create a market for the potentially blinding/ killer blockbuster arrhythmogenic Viagra sildenafil – which is rarely needed if the common relative androgen and other micronutrient deficiency of aging is simply screened for and appropriately corrected at trivial cost and no risk, with global health benefits.
It is common cause that sexuality (in both genders) starts declining as the serum testosterone falls below the average level of healthy youth – but Pfizer and the FDA have colluded tenaciously to conceal this fact in refusing for years to disclose the mean and range of testosterone levels of the men who were included in the infamous Viagra trials. Yet simple testosterone, magneium and fish oil are the major antiarrhythmic drugs- and most people die suddenly, from arrhythmia as the terminal event.

Antimicrobials aside, statins and all other modern drugs for chronic prevention are designed to target symptoms, not the root cause of diseases- so modern chronic drugs do not significantly reduce all-cause mortality and common major diseases of aging. The last thing the trillion-dollar Disease Industry wants is effective cheap prevention that can reduce by 90% the need for modern drugs, high-tech investigations and admissions to hospitals.

So the Disease Industry and it’s myriad beneficiaries – shareholders and staff, the FDA, Governments, academics, clinicians and politicians everywhere- desperately want to suppress and regulate access to and supply of the simple safe combination of natural proven drugs – the nutritional supplements like appropriate niacin, fish oil, and a few score other vitamins, minerals and biologicals (mostly also insulin sensitizers like appropriate sex hormone replacement/HRT, metformin/ galega etc) Together these unprofitable old drugs do vastly better in halving all common major chronic degenerative diseases of aging than fraudulent wannabe designer patent drugs like statins (and non-steroidal, anti-osteoporosis, anti-diabetics, anti-obesity, anti-depressants, and hormone substitutes) that are allowed by Regulators (like Congress and politicians everywhere, the tool of the lucrative drug industry – Only Disease Pays) to poison millions - the Innocent Survivors - Elaine Feuer’s famous 1997 expose..

AND Just in case you thought statins were “benign” drugs…. from the University of Cape Town Drug Info Centre-
The February 2008 issue of ‘Drug Safety Update’ from the MHRA notes that product information for statins is being updated to reflect a number of different side-effects which appear to be a class-effect of these medicines. The following prescribing advice is given:

• Statins may very rarely be associated with interstitial lung disease. Patients should seek help from their doctor if they develop presenting features of interstitial lung disease such as dyspnoea, non-productive cough, and deterioration in general health (e.g., fatigue, weight loss, and fever)

so, why take statins? unless you have severe lipidemia, stop them, take supplements that are far better. But discuss this with your doctor.

ndb