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At Last: Patients Should Be Told That Statins Aren't As Safe As They Had Been Led to Believe!
The November 2009 issue of the Drug and Therapeutics Bulletin (2009;47:123) criticises a delay in the implementation of February 2008 advice from the Medicines and Healthcare products Regulatory Agency about informing patients of side effects associated with statin use (PJ, 9 February 2008, p144).
In February 2008, there was a European-wide review on the cholesterol-lowering drugs called statins. As a consequence, new advice and product information should have been available to the public on the adverse side effects, of which there are many. See my 2007 paper where doctors refused to accept statins' side effects. (Below, you'll see that at least one high-profile British doctor - Miriam Stoppard - still does.)
The review prompted a long fight, as the drugs' manufacturers have fought tooth and nail to stop the review being published without changes to the wording to emasculate it.
"In other words, a drug company has been able to stall the inclusion of key safety warnings. In our view, this situation is unacceptable and should be rectified quickly," the Bulletin says, adding that the delay suggests that EU regulatory systems are more sensitive to the needs of the pharmaceutical industry than the welfare of patients.
Statins are one of the most important and widely used medicines in patients with lipid disorders and in the prevention of cardiovascular events. The efficacy and safety of statins have been studied in a number of large trials for both primary and secondary prevention of cardiovascular disease showing that overall, statins can reduce heart attacks and the need for bypass surgery and similar types of operation, and even save lives for certain patient groups. Trials have also shown that statins are generally well tolerated by most people who use them.
But overall death rates have not been shown to be reduced, and there are significant risks of serious side effects. The review identified the need for the product information for all statins to reflect the issues identified from analyses of clinical trial and postmarketing data from case reports of adverse drug reactions. These included:
- Long-term, irreversible muscle damage
- Sleep disturbance,
- memory loss,
- sexual dysfunction,
- depression,
- interstitial lung disease
- deterioration in general health
- fatigue
- weight loss
- fever
The review concluded that it was important that prescribers and patients alike are aware of the potential for these adverse reactions. And based on this evidence, Summaries of Product Characteristics and Patient Information Leaflets are being amended to include the potential for these reactions.
Too little, too late?
Considering how long statins have been prescribed and for how many people, this review is long overdue. This was a very long time overdue. Although it is too little and far too late for many sufferers, we must hope that it has a salutary effect on clinicians. But judging from the disgraceful reply to the news by Dr Miriam Stoppard, published on her blog at The Daily Mirror (http://blogs.mirror.co.uk/dear-miriam/2009/11/dont-panic-about-statin-side-e.html) there are some who still cannot bear to admit they might be wrong.
In reply to Dr Stoppard's remarks, Dr Jeff Cable writes:
It appears to be the case that Dr Stoppard has forgotten her basic clinical chemistry. There is no such thing as 'good' or 'bad' cholesterol. Cholesterol is an essential substance in the body as Dr Stoppard ought to know.
Why is there is no demonstrable correlation between the intake of cholesterol in the diet and the level of cholesterol in the body? Why does the brain need cholesterol in huge amounts? How is the protective sheath around nervous tissue (Myelin) created without cholesterol? Can you point to a single study, in the medical literature, that proves that lowering this essential substance reduces heart disease?
Many neurodegenerative conditions are now being ascribed to statin use. Amyotrophic Lateral Sclerosis, Alzheimer's disease and Parkinson's disease. Check the mevalonate metabolic pathway, Dr Stoppard, and you will see which other essential life processes are being inhibited by statins. It is not a question of if statins will damage you but when will they damage you.
The original patent mentioned CoQ10 as a means of counteracting the damage, which was known would occur following the inhibition of cholesterol synthesis. As far as I can tell, CoQ10 is not prescribed as an adjunct to statin therapy.
Rather than obscuring real facts, the medical profession should tell patients the truth about what statins are doing to achieve the needless reductions in cholesterol. If cholesterol was the progenitor of heart disease, tell me why 20 years of statin therapy have not reduced heart disease.
As for clinicians who claim any treatment is a miracle... it begs the question as to whether you are a clinical scientist or a shaman.
Statin Drugs Cause Muscle Damage Even After You Stop Using Them
A week after this news was published, naturalnews.com published an article showing that cholesterol-lowering statin drugs may cause serious and long-term muscle damage that persists even after the drugs are halted. This may be too late to be included in the revised paperwork.
What cholesterol does and why it's not a good idea to lower it.
Lastly, our bodies make cholesterol for a reason. Cholesterol isn't a harmful alien substance that should be avoided at all costs; it is arguably the most important molecule in our bodies, a substance we could not possibly survive without. For a technical description of all that cholesterol is used for, see this paper
Good News
Because of reports such as this one, sales of statins have reportedly fallen by some 20% already. Doctors like Miriam Stoppard might think about how their patients will react if 'told' that they must endure the ill-health that statins inevitably bring, sooner or later.
Last updated 12 November 2009
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