(N.B. This article only studies the use of statins as a preventive measure by healthy people against a first heart attack or stroke.)

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When NASA astronaut Dr. Duane Graveline had a heart attack he was prescribed the statin Lipitor (atorvastatin) to reduce the risk of recurrence. Six weeks after going onto the drug he lost a chunk of his memory for six hours. During that time he recognised neither his wife nor his house. On recovering, Duane immediately took himself off Lipitor but was persuaded to give it a second chance a year later. This time it took twelve weeks before an attack of transient global amnesia (TGA) wiped out everything since early childhood for twelve hours. There are now hundreds of examples of statins causing TGA. What would happen if, say, an airline pilot, a bus driver or a surgeon had an attack?

Four factors mean that we will probably soon find out ...

• the UK Government’s decision in July 2004 to allow citizens to self-medicate with a statin by making Merck’s Zocor Heart-Pro (simva-statin) available over the counter

• statins’ astonishing power to reduce levels of low-density lipoprotein cholesterol (LDLC) in the body

• the persistent belief in both most of the medical profession and the general public that LDLC is ‘bad’ and a major factor in heart disease and stroke

• new LDLC guidelines from the US Government’s National Cholesterol Education Program recommending 30% cuts in target LDLC levels for patients at high risk (see Ed.)

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Cancer
Amnesia is not the only problem. Studies have found increased risk of developing cancer, particularly in older people. A good example is the recent PROSPER trial, which found a 25% increase in newly diagnosed cancers among older people after four years treatment with pravastatin, in particular breast and gastrointestinal cancers. The researchers tried to characterise these findings as a ‘blip’ because a recent review of eight previous statin trials that lasted three or more years had shown no overall statistically significant differences in cancer incidence between placebo and statin groups. This comparison was unscientific. Most of these eight trials had used younger individuals. Because cancer risk increases with age, older people are likely to be far better indicators of any cancer-promoting capacity of statins.

Furthermore, PROSPER did not check for skin cancer, a serious omission. In relatively short-term trials like the majority carried out on statins to date, it is crucial to measure the incidences of cancers which show and can be detected early. This is likely to give an indication of a drug’s potential to increase the risk of slower-developing cancers long-term. Two trials of Zocor (simvastatin) have found increased non-melanoma skin cancer incidence despite, again, in the case of the Heart Protection Study, unscientific attempts to play down its significance.

In the CARE trial twelve women in the group receiving statins developed breast cancer, compared to only one in the control group. This is a highly significant difference even though three of the twelve women in the statin group who developed breast cancer had had it before. The possibility that statins will increase the risk of cancers is strong.

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Congestive heart failure
Ironically, statins are also blamed for the epidemic of congestive heart failure (where the heart is unable to maintain an adequate circulation of blood) sweepng the US. Figures from the US National Center for Health Statistics show that, since the early ’90s, when statins first became available, the incidence of congestive heart failure (CHF) has risen sharply. Their equally powerful ability to deplete the body of Co-enzyme Q10 (CoQ10) is blamed. Sadly, there is no cure for CHF short of a heart transplant.

Statin manufacturer Merck & Co. (and probably others) knew that this would happen, and that adding the co-enzyme into their statin preparations would probably reduce the increased risk of CHF without lowering their drug’s LDLC-lowering powers. Although it was granted patents in 1990, it never produced a CoQ10-enriched statin and never warned GPs that they should advise their patients to complement their statins with CoQ10.

Do statins reduce a healthy person’s risk of a first heart attack or stroke?
Studies have consistently failed to find any significant evidence that a healthy person can reduce her or his risk of a heart attack or stroke by taking statins more effectively than by what researchers refer to as “usual care” (maintaining proper body weight, stopping smoking, regular exercise, healthy diet, etc). Many other studies have found no link between statin-reduced LDL cholesterol levels and reduced risk of death from heart attack or stroke. This is probably because, although statins are potent cholesterol reducers, cholesterol is not a major factor in these diseases. The ALLHAT-LLT trial is a good example. The researchers compared the health outcomes of 5,170 people on statins and 4,830 people applying ‘usual care’ for four years. The individuals in both groups all had moderately high levels of LDL cholesterol. Over a quarter of the statin group lowered their LDL levels compared to only a tenth of the ‘usual care’ group, but the groups’ rates of death, heart attack and heart disease were identical. The PROSPER trial made the same point, but the other way round. The subjects with the highest survival rates were among those with the highest LDL levels.

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When levels of both total cholesterol (TC) and LDL cholesterol were declared major factors in heart disease and stroke, the researchers missed the obvious. High TC and LDL levels are well correlated with age, probably the risk factor for heart attack and stroke. If studies results are recalculated taking age into account, there is very little correlation between cholesterol and heart attack or stroke: certainly none sufficiently significant to predict an individual’s risk of developing these diseases.

Inadequate levels of cholesterol
Researchers now realise that statins themselves pose a serious health risk because they are too good at inhibiting the liver’s production of cholesterol, probably the explanation for the diseases and adverse side-effects listed above. Adequate levels of both high and low density cholesterol are essential to many key body functions, and no-one has yet established how much cholesterol levels can be lowered, if at all, without damaging other body processes. For instance, cholesterol forms part of every body cell’s membrane, where it helps renew vital components called phospholipids. Inadequate levels may cause cell membrane degeneration in both neural and muscle tissue. Studies have linked inadequate cholesterol levels to higher risk of cancer, brain damage, stroke, Alzheimer’s disease, aggressive behaviour, suicide and death.

Vitamin C to maintain a good cholesterol balance
The liver produces several thousand milligrams of cholesterol every day to carry out many essential bodily functions. Any excess cholesterol is converted to bile acid and then excreted. This continual recycling of cholesterol happens naturally when the body contains sufficient vitamin C (requiring 2-3gm per day intake for an adult). If vitamin C intake is insufficient, cholesterol builds up in the bloodstream. It is here that most doctors make a critical error. Instead of advising improvements in diet, or vitamin C supplementation, they prescribe statins.

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Will the Department of Health save money?
According to The Lancet’s editor, Dr. Richard Horton: “It is difficult to avoid concluding that the motive behind the Government’s decision is saving money. Statins are currently prescribed to about 1.8 million people in the UK, costing the National Health Service £700 million a year. With the NHS bill for statins predicted to (rise to) more than £2 billion a year by 2010, transferring costs to patients might seem timely.“

The UK's Department of Health will certainly avoid increased spend through this measure in the short term, but it is likely to generate massively increased costs in the longer term. Statins have already been linked with increased risk of serious (and expensive) diseases, including skin and breast cancer, heart failure and neurological damage (both by depleting the body’s levels of Co-enzyme Q10), rhabdomyolysis (severe breakdown of skeletal muscle tissue that causes muscle damage (the heart is a muscle) and can cause death through kidney failure), and transient global amnesia (see below), as well as a myriad of other unpleasant side effects like extreme fatigue, nausea, gastrointestinal problems, and muscle weakness and pain. Frequent side effects are probably the major reason why up to 75% of people taking statins discontinue their use and statin trials experience such high participant drop-out rates. The studies which identified these increased risks and side-effects were often only four or five years long. Increased risk of more diseases will emerge as people use them long-term. Some doctors are already prescribing statins for children with high cholesterol levels!

The UK decision is likely to lead to a global statin-driven pandemic as other Governments follow suit. There is already a strong pharmaceutical company-led lobby for over-the-counter statins in the US. Statin manufacturers regard the over 65s as a particularly lucrative market sector. Not only are they the most prone to and fearful of heart disease and stroke, their numbers are predicted to double t0 300 million worldwide in the next 30 years. The sector is also largely untapped. Only 2% of Europeans over 65 take statins at present.

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Editorial

The National Cholesterol Education Program guidelines
There may be nothing to it, and their review of the latest research (further vetted by 90-100 outside experts) may be completely accurate and objective but, of the nine experts who then went on to write the new 2004 National Cholesterol Education Program (NCEP) guidelines calling for 30% cuts in target LLDC levels, at least six had received consulting or speaking fees, research money or other support from the manufacturers of the most widely used statins.

For what it’s worth, in NCEP terms, ‘very high risk’ means people who have just had a heart attack or those who already have cardiovascular disease plus diabetes, are persistent smokers and have high blood pressure, or have other multiple risk factors. The LDLC top level guideline, previously 100 milligrams per decilitre (the equivalent of 2.6 millimoles per litre, the measure used in the UK and Europe) is no 70 (1.8mmol/L).

For ‘moderately high-risk’ people, those who have multiple risk factors and are estimated to have a 10-20% chance of heart attack or cardiac death within ten years, treatment with statins is recommended if LDLC levels are 130+ (3.3+), with optional therapy if levels are 100-129 (2.6-3.3).

The NCEB guidelines have not changed for those in the ‘lower’ to ‘moderate risk’ categories. ‘Moderate risk’ individuals should be keeping their LDLC levels at 130 (3.3) or lower, ‘lower risk’ individuals to 160 (4.1) or lower.

See also Low cholesterol levels prove dangerous

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