The Great Cholesterol Deception
November 17, 2010
By Dr. Peter Dingle
Millions of Australians are prescribed cholesterol-lowering drugs – statins like Pravachol®, Zocor® and Lipitor® – each year at a cost of more than $1 billion dollars with very little, if any, benefit. In the US, some 40 million people currently take statins at a cost of more than $3.00 per pill, more than $1,000 per year, totalling more than $40 billion a year.
While there are many exaggerated claims and a lot of hype about the benefits of statins, there are also many studies showing no benefits at all. The pro-statin hype is based on the misuse and abuse of statistics.
Various independent studies in prestigious, peer-reviewed journals have shown that statin use in primary prevention – that is, to save lives – has minimal or no value in reducing mortality and certainly nothing that is considered anywhere near clinically significant to warrant their widespread use. It does not matter how one manipulates the statistics, the results just aren’t there.
In data gathered in 2009 from six trials, a review of the efficacy in lowering the risk of death with statins found virtually no difference between the treatment group and the control group.1 There are many more of these studies.
In an independent meta-analysis (when a number of studies are put together to achieve more statistical power) of randomised controlled trials in patients without CVD, statin therapy decreased the incidence of major coronary and cerebrovascular events and revascularisations but not coronary heart disease or overall mortality.2
Taking statins for a number of years will not reduce mortality: “Primary prevention with statins provides only small and clinically hardly relevant improvement of cardiovascular morbidity/mortality.”3 “Hardly relevant” means there is virtually no clinical benefit; as the authors of these particular studies are independent, they gain nothing by stating this.
Another review found that “current clinical evidence does not demonstrate that titrating lipid therapy (trying to lower cholesterol with statins) to achieve proposed low LDL cholesterol levels is beneficial or safe.”4 In other words, lowering lipids has no real benefit and has the potential for adverse effects.
Following up on this, in a major independent review of studies funded by the Ministry of Health of British Columbia (Canada) on statins and primary prevention, researchers reported that “statins have not been shown to provide an overall health benefit in primary prevention trials.”5 This is a government report carried out by an independent university yet its findings are still ignored.
The problem really comes down to vested interests and the abuse of statistics. To overcome the limitations of small studies, vested parties combine many studies into a meta-analysis. The researchers themselves select the studies used in the meta-analysis. A fundamental problem is that researchers with direct links to drug companies have the authority to select the most positive studies and ignore the rest – including independent studies not funded by pharmaceutical companies. Despite this, they have still not been able to show any clinically significant findings.
As readers of the scientific journals, we should not be confused between statistical significance and clinical significance. For an outcome to be “statistically significant” means that the outcome was likely a result of the treatment – whether the result was 100% effective or less than 0.1% effective. That is, if you treat 1,000 people to save one life (0.1%) it may be statistically significant but it is not clinically significant. “Clinical significance” means 20% to 30% or more. The drug companies’ most positive studies on statins for prevention of CVD report statistical significance, mostly 1% or less, and none have found any clinical significance.
Busy medical professionals don’t have time to review the statistics; few of them may be aware of the different ways the statistics are manipulated. So if the experienced professionals don’t understand the results of these studies, how do we expect the media or public to understand?
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