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Monday, 24 March 2014

Dr Malcolm Kendrick: Statins aren't a wonder drug

The claims made for statins are overblown. They are not a cure for most of the major diseases afflicting western civilisation

Statins are the most widely prescribed drugs in medical history. They appear to have effortlessly conquered heart disease. If guidance proposed by Nice – the National Institute for Health and Care Excellence – is followed, 15 million people in the UK, most with no history of heart disease, could soon be taking them.
recent study by researchers at Imperial College London made the claim that "statins have virtually no side effects, with users experiencing fewer adverse symptoms than if they had taken a placebo". This can only mean that statins make people feel better.
The Oxford University professor Rory Collins this weekend accused critics of the drugs of misleading the public. Increasingly, statins are being promoted for use in a vast range of diseases – as a potential cancer cure, a drug to prevent organ rejection, and as cures for Parkinson's disease and dementia. Now it is announced that statins reduce brain shrinkage in multiple sclerosis.
Can all of this be true? Is it possible for a drug to have no side-effects at all, and still cure most of the major diseases afflicting western civilisation? Well, of course not. However, through a vast marketing budget, and the fact that most doctors believed that cholesterol causes heart disease, statins have managed the ultimate product goal of becoming "good" and highly benevolent.
The pharmaceutical industry has created a monster. While statins are now almost entirely off-patent – so they make very little profit nowadays – at their peak they were a sales colossus. The marketing spend for Crestor alone was $1bn in the first year. Atorvastatin (Lipitor) at one point was making £13bn a year. Trial upon trial was set up and hyped. The marketing machine was relentless. Resistance was futile.
But the monster may be one that no one can now kill. The industry may come to rue its creation, once it has to sell the new generation, patent-protected, cholesterol-lowering agents waiting in the wings. How can you better a statin, these life-enhancing wonder drugs? It will be a tough task.
As for the recently hyped benefits in multiple sclerosis – are they real? It is difficult to say. Drugs can start out doing one thing, then be found to have many other effects. Aspirin started out life as a painkiller. It was then used in arthritis. It moved on to treat heart attacks, and next prevent heart attacks. Now it is used to prevent cancer.
However, drugs which appeared to have marvellous "test-tube" effects have often ended up badly when researchers looked for real clinical benefits. Encainide suppressed dangerous heart arrhythmias, but waspulled from the market for killing thousands of people. Avandia reduced blood sugar levels, but was found to increase the risk of heart attacks. Ezetimibe is marvellous at cholesterol-reduction, but has no benefit on heart disease. So, will statins really benefit MS? I tend to doubt it.
It is clear that statins don't wipe people out in vast numbers. But they can have adverse effects, some of which are very severe, including a significant increase in type 2 diabetes. Cerivastatin was pulled from the market for causing a significant rise in rhabdomyolysis – disintegration of muscles, often followed by death. Atorvastatin, otherwise known as Lipitor – the statin top of Nice's list of recommendations – has never been demonstrated to increase life expectancy. So, taking the drug may change what is written on your death certificate, but it will not alter the date.
As a lady recently wrote on my blog: "I have MS and I was told over 15 years ago that statins are 'good for MS because they decrease inflammation'. Did not believe it then and don't believe it now. Of course between then and now I was put on statins for cholesterol. Stopped about five months ago and feel GREAT!"
Graham

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