Monday 28 February 2011

"Statins for all"- and billions for drug firms

By James Le Fanu

Prescribing them to the healthy may not have saved lives, but it certainly made money.


Back in 1975, Henry Gadsden, the chief executive of the drug company Merck, expressed his frustration that the market for his company's products was limited to those with some treatable illness. Ideally, he said, he would like to "sell to everyone".
Three decades later, his dream would seem to have come true – epitomised by the most profitable class of drugs ever discovered, the cholesterol-lowering statins that are taken by an estimated seven million people in Britain, and tens of millions worldwide.
Statins are frequently portrayed as the wonder drugs of our age, whose role in reducing the risk of heart attacks and strokes prevents tens of thousands of deaths per year. But not according to the most recent review of the many trials investigating their effectiveness, published yesterday. It suggests that for three quarters of those taking them, they offer little or no value, while exposing millions to the hazard of undesirable side-effects.
But if that is the case, how did statins become so popular? Their remarkable rise is tribute to the success of the immensely rich and powerful drug companies in pursuing their goal of "mass medicalisation". The story starts with the arrival of "cholesterol consciousness": the thesis that those indulging in (for example) bacon and eggs for breakfast boosted the cholesterol level in the blood, causing the arteries to become narrow, and making a heart attack more likely.
Although this idea has its critics, there is no doubt that the small proportion of the population with a genetic predisposition towards high cholesterol levels are at greater risk of circulatory disorders. Encouraging them to switch to a healthy diet had failed to lower that risk – so the idea gained ground that cholesterol-lowering drugs might be the answer.
And so it turned out. The first statin, Lovastatin, was launched in America in 1987. It was accompanied by a national education programme run by a panel of independent experts, which encouraged everyone to drop into their doctor to get their cholesterol checked, and to take medication if it was found to be raised. By the mid-1990s, statins were generating $3 billion a year. Today, that is $26 billion – a single class of drugs producing more revenue than Google.
The key to this extraordinary phenomenon has been the amazing success of the drug companies in persuading doctors and the public that, just as the high-risk minority benefited from lower cholesterol, so would everyone else. Here, two factors have been of particular significance. First, several drug companies, recognising the bounteous potential of Lovastatin, promptly came up with their own versions. In the subsequent scramble to secure a share of the market, the clinical trails also served as an ingenious and highly successful form of marketing. Given catchy titles, they were organised on a massive scale, involving up to 10,000 patients. The effect of the inevitably favourable results, announced with great razzmatazz at major medical conferences, generated evangelical enthusiasm for the project of "statins for all".
An even more important factor, especially in the US, was the drive to establish "clinical practice guidelines", under which panels would set the optimal treatment for any given condition. Successive guidelines have forced the "normal" level of cholesterol ever lower, resulting in leaps in the numbers deemed eligible for treatment. In the US, the figure went from 15 million to 40 million. After it was pointed out that those responsible for the most recent guidelines had failed to declare any potential conflicts of interest, it subsequently emerged that most of them had received research grants or consultancy fees from the drug companies involved in manufacturing statins.
In Britain, similar guidelines require doctors to measure the cholesterol level of any patient dropping in to see them for any reason, irrespective of their age. We GPs have not only been ordered to commence treatment where deemed appropriate, but are given a financial incentive for doing so. This has perhaps proved a step too far, as it has led to statins being widely prescribed to the otherwise fit and healthy. Often, this is where the side-effects appear: those previously accustomed to taking regular exercise have reported being reduced to a state of near decrepitude by muscular aches and pains, while the alert suffered memory lapses of such severity as to suggest incipient dementia.
What is the bottom line? First, that there are strong theoretical grounds for supposing that statins are not nearly as effective in preventing heart disease and strokes as they are portrayed. This certainly applies to the vast majority of users, whose cholesterol is deemed "high" by the guidelines, but who are otherwise healthy. The main finding of this new review, and a similar one last year, is that for such people, statins have no effect on mortality either way. In contrast, for men – but not women – under 70 with a history of heart problems, they do indeed save lives.
It would be good to think that this saga might prompt some soul-searching among doctors about the adverse consequence of the over-intimate relationship that has developed between the profession's "key opinion leaders" (as they are known in the pharmaceutical business) and the drug companies. We will see.
1 comment:
Statins represent the totally ruthless approach to marketing by Big Pharma with drugs that can do more harm than good, and GPs compliant because of the pressure on them. Lets first establish the fact that 75% of heart attack victims have normal choloesterol levels so the question is what causes them? Certainly not cholesterol. Cholesterol is itself absolutely essential for body, heart and brain health. Inflamation and oxydation can cause problems so these are major triggers. Homocysteine is a major trigger but these can be neutralised by vitamin B1, folate and vitamin B12 - but in healthy amounts which are 30 times greater than the totally nonsensical recommended daily amounts (RDA) which are at the opposite spectrum to optimal health.

Arterial health is dependent on optimal nutrition especially vitamin C, and again in quantities much greater than the RDA which only just prevents scurvy - but not coronary heart disease. Arteries are flexing in direct response to every heart beat so frequently little bits peel off from the arterial wall and are replaced if nutrition is adequate - that is substantially greater than RDAs. If not adequate then the brain instructs cholesterol to fill the gaps which means that after time the arteries start to get thicker and loose their normal flexibility and high blood pressure results. In addition pieces of cholesterol can break off the arterial wall and create strokes and heart attacks.

As will be seen statins are not the main solution but are a major cause of ill health and death - yes death! Allow me to explain. Cholesterol is produced by the liver when needed and when functioning properly. The brain has its own production of cholesterol as a safety factor because cholesterol is also vital for brain health. Statins reduce production of cholesterol from the liver and brain. IN addition statins reduce another vital substance produced by the liver called CoEnzymeCoQ10. This enzyme is absolutely vital for cellular health - that is every one of the 100 trillion cells in your body and brain. Every cell has fuel sources called mitochondria without which they cannot function properly and if the fault is not rectified it results in cell death. CoEnzymeCoQ10 is a vital fuel source for the mitochondria. When cellular levels drop because of statins, alarming side effects result, many of which are mentioned here. Sadly, omitted, is congestive heart failure and when the patient (victim) dies, which is a frequent occurrence, the cause of death on the death certificate states myocardial infarction, but not statins. AS the heart muscle is the hardest working muscle in the body, every cell contains a very high number of mitochondria so serious problems will occur when it cannot obtain adequate levels of CoEnzymeQ10.

When statins were first marketed, a pharmaceutical company patented a combination of statin and CoEnzymeQ10 on the basis they knew what the drug (statin) would do to the mitochondria, but in the end did not market the combination product. All manufacturers should be well aware of what the serious consequences are for reducing supplies of vital CoEnzymeQ10 to all cells in the body, but none to my knowledge have promoted this enzyme in order to save lives. Of course, CoEnzymeQ10 is a natural product so cannot be patented and therefore is of no interest to Big Pharma because they cannot make mega profits. Just as the B vitamins are natural and cannot be patented but can successfully halt homocysteine, Big Pharma come up with statins which are patentable. This practice is reflected accross the full spectrum of drug manufacture.

Big Pharma virtually control the medical profession, including the regulators, which is why their biggest competitor, nutritional medicine and herbal medicine are under attack under the totally false guise of safety. No one has ever died from nutrients/vitamins, but it is estimated that every year 20,000 die, 100,000 are hospitalised and 1,000,000 injured evey year by taking drugs as prescribed by their GP. In addition there are the 40,000 killed in hospitals because of accidents and infections such as MRSA.

Drugs as produced by Big Pharma are primarilly designed to treat symptoms and not to cure the illness. Over 50% are no better than a placebo, but placebo's do not harm and kill. Drug manufacturers carry out their own research and present results to the regulators for licensing, but these results are all to frequently exposed subsequently as being economical with the truth, because safety fears become evident after market release. This is called the GOLD standard of medicine.

Full marks to Dr Le Fanu and The Daily Telegraph for this lead article exposing at long last the travesty that is statins.

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