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Government Health Agencies Complicit in Cholesterol Ruse

_http://www.doctorsaredangerous.com/articles/statin.htm_

(http://www.doctorsaredangerous.com/articles/statin.htm)

by Bill Sardi

The revelation that statin cholesterol drugs may be of little or no benefit,

as revealed in _a lengthy cover story_

(http://www.businessweek.com/magazine/content/08_04/b4068052092994.htm)

_http://www.businessweek.com/magazine/content/08_04/b4068052092994.htm_

(http://www.businessweek.com/magazine/content/08_04/b4068052092994.htm) in

January 28 issue of Business Week (BW)

magazine, begs the question: how did this misdirection go on for so long?

As the BW article pointed out, statin drugs " are the best-selling medicines

in history, used by more than 13 million Americans and an additional 12

million patients around the world, producing $27.8 billion in sales in 2006. "

How can anyone question the benefits of such a drug, asks BW, when they are

" thought to be so essential that, according to the official government

guidelines from the National Cholesterol Education Program (NCEP), 40 million

Americans should be taking them. Some researchers have even suggested –

half-jokingly – that the medications should be put in the water supply, like

fluoride

for teeth. And it's almost impossible to avoid reminders from the industry

that the drugs are vital. A current TV and newspaper campaign for one statin

drug, as endorsed by Dr. Robert Jarvik, artificial heart inventor, proclaims

that this drug ‘reduces the risk of heart attack by 36%...in patients with

multiple risk factors for heart disease’. "

Statin drug ruse revealed

But the cholesterol/statin drug ruse finally unraveled when, after two years

of foot dragging delays to release data from a large study involving Zetia,

a cholesterol-lowering drug that inhibits cholesterol absorption from foods,

and Vytorin, which is a combination of Zetia plus Zocor, the latter a statin

drug that inhibits formation of cholesterol in the liver, revealed no health

benefits.

Even though this drug combo lowered circulating cholesterol numbers better

than either drug alone, it did not reduce plaque formation in arteries and did

not confer a projected reduction in mortality.

In fact, an earlier review published last year in the British journal Lancet

by Drs. John Abramson of Harvard Medical School and James M. Wright MD of

the University of British Columbia , could find no evidence for a reduction in

cardiac mortality in a combined review of all published statin drug studies.

[The Lancet 2007; 369:168–169]

Falsifying the numbers

The Business Week report says statin drugs benefit only 1 in 100 users, but

they claim to reduce the risk of a non-mortal heart attack by 36%. But that

figure is a relative number, not a hard one. About 3% of patients taking an

inactive placebo pill will experience a heart attack compared to 2% taking a

statin drug, which produces the so-called 30-plus percent risk reduction. But

in hard numbers, this is only a 1% reduced risk.

This type of misleading advertising wouldn’t pass Federal Trade Commission

guidelines. But public health agencies, serving as free publicity agents for

the statin drug manufacturers, repeat the claim to give it a ring of

credibility.

Complicity by public health agencies

Articles posted at _websites administered by the Food & Drug Administration_

(http://www.fda.gov/fdac/features/1999/199_chol.html)

_http://www.fda.gov/fdac/features/1999/199_chol.html_

(http://www.fda.gov/fdac/features/1999/199_chol.html) and the National

Institutes of Health repeat this misleading

claim. In fact, _a recent posting by the NIH_

(http://www.nlm.nih.gov/medlineplus/news/fullstory_59400.html) claims statin

drugs reduce the risk for a sudden

death heart attack by 19%, when in hard numbers it is actually just 0.8%

(reduction from 3.8 to 3.0% over 4.4 years).

How did the FDA ever approve these drugs except to ignore these facts? Why

did the FDA allow pharmaceutical companies two years to report critical data

on the effectiveness of a life-saving drug?

Do benefits outweigh the risk for side effects?

For years there has been criticism that statin drugs are not totally safe,

that they produce muscle aches and mental problems. But advocates for statin

drugs have repeatedly claimed the benefits of statin drugs far outweigh any

risks, said to occur among 2–3% of users. But the BW report cited side

effects

occur among 10–15% of users, which is backed by current research. [Current

Opinion Lipidology 2007 Aug;18(4):401–8] The risks for serious side effects

far

outweigh any alleged benefits.

Collusion by medical journals

Others in modern medicine are also complicit in this subterfuge. The

following is an example.

On April 8, 2004 the New England Journal of Medicine published an

authoritative report about the use of cholesterol-lowering drugs among patients

hospitalized for acute coronary syndrome (acute heart attack or highly unstable

chest pain/angina). The study, conducted by researchers at Brigham and

Women’s

Hospital and Harvard Medical School in Boston , enrolled 4162 patients at 349

sites in 8 countries. [ New England Journal Medicine 350: 1495–1504, April,

8,

2004 ]

The study compared the use of standard-dose (40 mg) pravastatin (Pravachol)

with intensive-cholesterol lowering with high-dose (80 mg) atorvastatin

(Lipitor). The chart below appears to show a slight advantage (about 4–5%

difference) in reduction of mortality for the high-dose statin drug regimen.

This

slight advantage is shown as a 16% relative risk reduction in the published

paper. These relative numbers are used to magnify the effects of these types of

intensive drug regimens. Examine the chart below, as published in the New

England Journal of Medicine:

 

OK, the complicity of modern medicine in this crime is documented in print.

The New England Journal of Medicine published a correction of the above

numbers two years later ( Feb. 16, 2006 ), in an obscure back page of the

Journal.

The following is a scanned image of that correction notice.

 

Here are the corrected numbers (number at risk):

`

6 months

12 months

18 months

24 months

30 months

Standard therapy

`

`

`

`

`

Pravastatin:

1701

1542

1449

896

224

Atorvastatin:

1752

1590

1515

950

231

Intensive therapy

`

`

`

`

`

Intensive high-dose statin drug therapy (atorvastatin) appears to have

slightly increased the risk for death rather than reduced it. There was no

explanation as to why the initially-reported numbers were incorrect, nor why

the New

England Journal of Medicine didn’t withdraw this paper, which still misleads

many. Nor why doctors at the above-mentioned medical institutions didn’t

seek wider exposure for this correction.

Do statin drugs mimic a vitamin?

In 2006 Dr. Davis S. Grimes of the Blackburn Royal Infirmary in Great

Britain, ruffled a lot of feathers in the medical world when he revealed that

statin drugs appear to be synthetic versions (called analogs) of vitamin D.

[Lancet 2006 Jul 1; 368(9529):83–6] All the alleged health benefits of statin

drugs, prevention of osteoporosis, cancer prevention, promotion of arterial

health, parallel those of vitamin D. The pharmaceutical world was quick to deny

the

allegation.

In his report entitled " Are statin analogs of vitamin D? " Dr. Grimes claims

that the concept of statin drugs may come from vitamin D as they appear to be

molecular alterations of this vitamin. A more recent study confirms that

statin drugs modestly increase vitamin D levels. (See chart below.)

Drug Status

Took drug or inactive placebo

Vitamin D level

(nanomole/Liter of blood)

No statin

Active

Placebo

65.9

38.4

On statin

Active

Placebo

74.0

50.0

Source: American Journal Cardiology 2007 October 15; 100(8): 1329.

Liver toxicity turned into a health benefit

Because these statin-drug vitamin D analogs had toxic liver side effects,

their pharmaceutical inventors appear to have turned this drawback into a

so-called advantage – that they inhibited cholesterol production in the

liver. For

comparison, any herbal product that raises liver enzyme levels would be

quickly withdrawn from the marketplace by the FDA and declared a liver toxin.

But

the FDA permits liver-toxic statin drugs to be marketed and sold to millions

of Americans.

Common health benefits of statin drugs and vitamin D

If statin drugs have any redeeming quality it is that they modestly raise

vitamin D levels. How would this common biological action of statin drugs and

vitamin D address the accumulation of plaque in arteries with advancing age?

You will be surprised to learn only about 3% of arterial plaque is

cholesterol and 50% is calcium. [international Journal Cardiology 1991 Nov; 33

(2):191–

8] Researchers in Germany point out that a deficiency of vitamin D induces

calcification and that " almost all atherosclerotic plaque in arteries are

calcified. " [Current Opinion Lipidology 2007 Feb; 18(1):41–6] End-stage

kidney

disease patients, who experience severe arterial calcification, have mortality

rates that are 10–20 times higher than the general population. [Current

Opinion Lipidology 18:41–46: 2007] The presence of arterial calcification is

a

predictor of poor 5-year survival.

Calcification results in stiff arteries. Cholesterol on the other hand is

soft and waxy and does not produce hardened arteries. Vitamin D is an

anti-calcifying agent. [seminars in Dialysis 2005 Jul–Aug; 18(4):307–14]

A vitamin D deficiency increases the risk for heart disease. [Circulation

January 7, 2008 ; Current Opinion Clinical Nutrition Metabolism Care. 2008 Jan;

11(1):7–12] Heart attacks occur more frequently in winter when vitamin D

levels are low. [Chronobiology International 2005; 22(6):1121–35;

International

Journal Epidemiology 1990 Sep; 19(3):559–63] The use of vitamin D supplements

reduces the overall risk of mortality at least seven times greater than

statin drugs. [Archives Internal Medicine 2007 Sep 10; 167(16):1730–7]

Modern medicine misdirected the public and many health professionals into

thinking cholesterol, not calcium, is the chief culprit in coronary artery

disease. By lowering a meaningless number, patients would derive a false sense

of

heart health, and doctors would maintain a high level of disease to treat.

Cholesterol or calcium?

It is instructive to compare the dietary intake of cholesterol and calcium

with the coronary heart disease and stroke mortality rates from various

countries. It is obvious that dietary cholesterol has no meaningful

relationship

with coronary heart disease and calcium does.

Relationship of dietary cholesterol and calcium to coronary heart disease,

by country

`

Japan

China

Britain

USA

Dietary cholesterol intake milligrams/day (mean)

Males

Females

 

446

359

 

218

146

 

299

220

 

348

244

Dietary calcium intake milligrams/day (mean)

Males

Females

 

605

607

 

356

256

 

1013

843

 

882

699

Mortality rates, age-adjusted stroke/coronary heart disease per 100,000

Males

Females

 

 

57

20

 

 

54

36

 

 

267

139

 

 

202

84

Source: Zhou BF, et al, Nutrient intakes of middle-aged men and women in

China , Japan , United Kingdom , and United States in the late 1990s: the

INTERMAP study. Journal Human Hypertension 17: 623–30, 2003.

Steer the public away from high-dose vitamin D

But something had to be done to distract the public away from taking vitamin

D pills. So a misleading claim was made that high-dose vitamin D actually

induces arterial calcifications and that pharmaceutical companies would have to

invent synthetic versions (analogs) of vitamin D that would not result in

calcification of tissues throughout the body.

While vitamin D does induce calcification, it requires a human equivalent

dose of 21,000,000 international units (IU) to do this. [Current Opinion

Lipidology 2007 Feb; 18(1):41–6] A person would have to take over 52,000

400-IU

vitamin D pills to do this.

Health directives from various public agencies attempt to steer the public

away from so-called high doses of vitamin D. An _online National Institutes of

Health guide_

(http://dietary-supplements.info.nih.gov/factsheets/vitamind.asp)

_http://dietary-supplements.info.nih.gov/factsheets/vitamind.asp_

(http://dietary-supplements.info.nih.gov/factsheets/vitamind.asp) says

2000 IU is the " upper safe limit. "

But this limit is absurd. About 30 minutes of total-body sun exposure to

midday summer sun would produce about 10,000 IU of natural vitamin D and

overcalcification does not occur from solar vitamin D production. Two people

inadvertently consumed sugar cubes over-fortified with vitamin D and their

intake

was 1.7 million units per day. It took seven months before headaches and

gastric side effects forced them to see a doctor, and the symptoms subsided

with

cessation of the use of the sugar cubes. [Lancet. 2002 Feb 23; 359(9307):672]

It’s time for the millions of Americans taking statin drugs to confront

their doctors, and inquire about substituting $3-a-day statin drugs for a

10-cent

vitamin D pill.

January 21, 2008

 

 

 

 

 

 

 

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