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24 Feb 2015
Considering the fact that February is Heart Month it may be of interest that the side effects of statins have been under renewed scrutiny. About seven million people in Britain take the cholesterol-lowering drug statins every day. This is one of the most commonly prescribed and taken drugs in Britain. These drugs lower the risk of heart attack by reducing the fatty deposits in the arteries therefore reducing risk.
Last July the National Institute for Health and Care Excellence (NICE) published new guidelines on these drugs changing the prescription guidelines from those patients deemed at 20% risk of heart attack to those at 10% risk. This new guideline will mean that up to 40 percent of the adult population will be eligible for statin prescription.
Bearing this in mind it is therefore quite concerning, or reassuring, depending on how you look at it, that there is now going to be a new review into the side effects of these cholesterol lowering drugs.
Sir Rory Collins who is co-director of the Oxford University’s Clinical Trial Service Unit and Epidemiological Studies Unit will re-examine medical records of thousands of patients who had previously been included in studies into the prescription drug. The main aim of this review is to evaluate the side effects of statins which have been widely reported. These side effects include such issues as muscular pain, memory loss and diabetes.
Dr Fiona Godless, the editor of the British Medical Journal commented that
“This is of real concern. We wrongly assumed all the details of possible side effects had been thoroughly assessed before new guidance made tens of thousands of people eligible for this drug. We now know this is not the case and would urge that any re-analysis be done in the most transparent way.”
Oxford’s Visiting Professor of Public Health Epidemiology Dr. Kim McPherson also commented,
“We know these drugs have side effects but we do not know if these have been assessed properly by the drug companies who carried out the trials. It is outrageous. Why do they not make their data available for scrutiny? Taking these drugs should be a matter of individual patient preference with patients fully aware of their risks, which at the moment is not the case.”
The NHS lists the side effects above plus others such as nose bleeds, problems with the digestive system amongst others as affecting 1 in 10 people. Other less common side effects include being sick, loss of appetite or weight gain, insomnia, nightmares, dizziness, peripheral neuropathy, ringing in the ears, blurred vision, feeing unusually tired, inflammation of the live or pancreas. Therefore the re-evaluation of the actual level of risk of side affects has been welcomed by Dr Fiona Godless and no doubt others. She said that the paper was based on data from an “uncontrolled observational study” and was incorrect.
Rather controversially, Dr Adam Fitzpatrick, a cardiologist and an expert in heart rhythm disorders at the Manchester Royal Infirmary, agrees pointing out that the evidence for statins still doesn't prove that they are responsible for fewer people dying of heart disease.
“Saying statins save thousands of lives a year is just propaganda. The mortality rate for cardiovascular disease has been falling for 50 years anyway – and it reflects other factors, including quality of care and diagnosis, not to mention the number of people stopping smoking. “We should be focusing on what the patient is complaining of. Our job is to tell them what it is caused by and reassure them, if that is appropriate. I see so many old ladies with atrial fibrillation who have been stuck on 80mg daily of the statin Lipitor and haven’t been able to move since due to muscle weakness. It is madness not to be tailoring care to those individuals.”
Interestingly this is rather challenges the idea that if there is any hint of CVD, people should be on statins. Although possibly if you are someone with a 10 percent risk of CVD you would not be questioning this? However, whichever camp you fall into this is a refreshing look at a massively prescribed drug, and provokes the question as to whether all drugs should in fact be regularly re-evaluated. As an aside it may be worth pointing out that clinical trials tend to be published in journals that are expensive to subscribe to and are therefore possibly not available for everyone to look at. And of course the average person actually relies on their doctor to give them the risks of side effects, but of course if the doctor doesn’t have the accurate information....
This is all refreshingly pointing towards the need to treat people more individually, as Dr Adam Fitzpatrick pointed out, we need to look at what people’s complaints actually are and what the cause of their symptoms actually is.
Cardiovascular disease is the biggest killer in England and Wales, constituting nearly a third of deaths each year and costing the NHS billions. But are statins the only answer? This re-evaluation may possibly leave some room for the importance of lifestyle and food in addressing cardiovascular disease. For example there is also growing evidence to show that sugar is very much implicated in CVD. Of course this opens up a whole new approach. Is it possible therefore that there is unnecessary ‘medicalisation’ and a need to take a fresh look at how CVD is assessed and treated?
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