Government Health Agencies Complicit in Cholesterol Ruse

The revelation that statin cholesterol drugs may be of little or no benefit, as revealed in a lengthy cover story in January 28, 2008, 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 and the National Institutes of Health repeat this misleading claim. In fact, a posting by the NIH 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 says 4000 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

DISCLAIMER

This information is not intended as medical advice. I encourage everyone to make their own health care decisions, with advice from qualified professionals.