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Why I disagree GPs have been 'misled' about statins

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On Friday the media aided and abetted an epidemic of misinformation by promoting a new review of statin data in The Lancet, without ascertaining crucial facts. To start with, it is not an independent review. As BMJ editor-in-chief Fiona Godlee said this is a review by the ‘trialists marking their own homework’ of the benefits of statins and rare side effects from industry sponsored studies. But the harsh reality is that the side effects are real and relatively common. 

It’s high time the clinical trials units allow access to raw data

I have been a GP for over 30 years and have written tens of thousands of statin prescriptions in my career. I too started taking statins in my late 50s and I’m Asian, so I ticked various boxes for being at raised risk of heart disease. It seemed the sensible thing to do. Within two weeks, however, I started experiencing pains in my back and legs unlike anything I had suffered before. Mostly it was a dull ache, but for a couple of days a week the pain was crippling and I had to take painkillers. This went on for two years and I had to give up badminton, my favourite form of exercise.

Initially, I assumed the pain was something that would pass. In fact, it worsened, and the bouts became more frequent. I had problems sleeping and started to wonder about possible causes. I didn’t even consider statins. I was wondering instead about things like too much travelling or bad posture when sitting. I did various checks, like a liver function test, X-rays and an MRI scan, straining the NHS’s already overstretched resources. All came back clear. I even saw a neurologist and underwent nerve conduction studies after months of facial muscle fasciculations.

Finally, I thought it was worth seeing what would happen if I stopped taking the statins. Within two to three weeks my back and legs began to feel a lot better, my sleep improved and my muscle tremors disappeared. For me that was the litmus test that showed that the statin was the cause of the problem.

The Lancet review does not contain any substantially new information or data. Many of the studies used in the analysis had pre-randomisation run-in periods which means that people who complained of side-effects from statins were excluded from the trial. As pointed out by cardiologist and editor of JAMA Internal Medicine Rita Redberg 35% of statin users were excluded during the open-label run-in TNT trial. Thus, the actual adverse events rate is certainly higher than in the trials.

None of the Oxford Clinical Trials Unit data has been made available to other researchers despite multiple requests, all of these data are from industry sponsored studies, with concern for bias and no one has seen these data except the trialists. In addition, adverse events are under-reported in these trials, as they do not ask about the common ones and many use a definition of muscle problems which requires a creatine kinase (CPK) increase, yet many patients have muscle weakness without CPK increase.

Reliable real world data suggests up to 20% of statin users have muscle problems. The higher estimate certainly reflects the many patients I saw when I was practising, who are or were miserable when put on statins. It’s instructive to note that pharmaceutical company Pfizer’s (the manufacturer of atorvastatin) own patient leaflet states ‘common side-effects that may affect up to one in 10 patients include sore throat, nausea, digestive problems, muscle and joint pain.’

Earlier this year two groups of researchers in Japan and France have independently questioned the reliability of many of the earlier industry sponsored studies that show the benefit of statins. Japanese researcher even suggests that statins may be a cause of the increasing population burden of heart failure and reputed French cardiologist Dr Michel De Lorgeril’s own analysis reveals that all studies published after 2006 reveal ‘no benefit’ of statins for cardiovascular prevention in all groups of patients. But De Lorgeril goes further, and calls for a full reassessment of all the statin studies. He states ‘physicians should be aware that the present claims about the efficacy and safety of statins is not evidence-based.’

It’s high time the clinical trials units allows access to raw data. This is the only way to reassure doctors and patients on the true benefits and side effects that interfere with quality of life.

Dr Kailash Chand OBE is a retired GP and former deputy chair of BMA council. You can follow him on Twitter @kailashchandobe

 

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Readers' comments (7)

  • I've been taking statins for years with no side effects. So does my personal anecdotal evidence cancel out yours? Since you question the statistical evidence it makes no sense to insinuate that your own experience has any statistical significance. Ditto for the non-blinded reports of possible side effects from your patients (who obviously knew they were taking statins) talking to a doctor who has a self reported bias.

    Your questioning of the evidence is a good thing, but the anecdotes are irrelevant.

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  • Anecdotal evidence is not irrelevant when the number of people reporting side effects reaches the thousands, as it does on social media.
    Many patients feel happier to report adverse effects to statins on social media rather than face to face with Gps who they feel are unsympathetic to their concerns.

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  • Anecdotal evidence is not irrelevant when the number of people reporting side effects reaches the thousands, as it does on social media.
    Many patients feel happier to report adverse effects to statins on social media rather than face to face with Gps who they feel are unsympathetic to their concerns.

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  • At present, it is estimated that approximately 7 million people in the UK take statins. If NICE guidance is followed the number could increase by several million. The evidence for the benefit in primary prevention– is weak.

    Perhaps more worryingly, statins provide false reassurances that may discourage patients from taking the steps that actually reduce cardiovascular disease. According to the World Health Organisation, 80% of cardiovascular disease is caused by smoking, lack of exercise, an unhealthy diet, and other lifestyle factors. Statins give the illusion of protection to many people who would be much better served, for example, by simply walking an extra 10 minutes per day, and avoiding processed food.

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  • This comment has been moderated.

  • Ivan Benett

    I'm afraid you're just plain wrong. The trouble is you'll be putting off people who have a clear benefit from Statins, namely those with know Caroronary Artery Disease.
    The controversial area is in Primary prevention, and the discssion has been about the threshold of risk at which to start statins AFTER lifestyle advice. Unfortunately this then becomes a nuanced discussion with patients and doctor factors become influencial. At lower risks the absolute benefit becomes small, but this is a judgement individuals have to make, in consultation with their GP. Blanked statin good or statin bad is too simplistic.
    But the balance in favour of statins for known CVD is clear

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  • Why can't we accept that statins are good but as with every medication not every patient can tolerate the drug.
    Just like hypertension.
    We find suitable antihypertensives but with statin we have few choices and if Pt is able to tolerate then we must accept that it's not be all and end all
    I could not take beta blocker or ace inhibitor and my GP had to find suitable antihypetrmise but with statin I will draw a line eithe I can or can't take
    I need to learn drastic life style change so do my patients
    We have to look at the practicality - pt's wellbeing....?

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  • The evidence which nobody disputes is that one Lives 5 to 20 days longer taking statins!
    A recent study in the BMJ provided an answer. (doi:10.1136/bmjopen-2014-007118) Death was postponed between 5 and 19 days in primary prevention trials and between 10 and 27 days in secondary prevention trials! Do you still like to medicalise millions of people with statins?

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