This month, I co-signed a letter, along with a number of eminent physicians, calling for a full parliamentary investigation into statins. In response, the recipient, Sir Norman Lamb MP, chair of the science and technology committee, wrote to chief medical officer Dame Sally Davies, calling for a review. Our call was based on the lack of clarity on the real benefits of the drug and true incidence of side effects.
I was, therefore, horrified to learn a few days later that NHS England are pushing for high-dose statins to be dispensed across pharmacies, without the need for prescriptions. I believe this will cause considerable damage to public health.
I’ve even taken calls from numerous GPs who are alarmed at this proposal by NHS England chief executive Simon Stevens at his Expo address.
All too often, we see powerful interests use science to sway opinion.
In the hands of pharmaceutical industry propagandists, outsider studies have become powerful weapons of misinformation.GPs have no problem using high-dose statins in patients who have already had a heart attack or stroke, as they’re at very high risk of further episodes, and there is some evidence of benefitting that group. Despite this, the data on an individual basis is quite underwhelming.
According to non-transparent industry-sponsored studies taken religiously for five years, heart attack patients can at best expect a one in 83 mortality reduction and a one in 39 chance of preventing a non-fatal heart attack.
But for those who haven’t had a heart attack or stroke, starting a long-term statin brings no mortality benefit.
Prescribing drugs without explaining the absolute risk reduction is both unscientific and unethical. The RCGP is right to raise concerns that this news could lead to people being misdiagnosed and wrongly treated by pharmacists.
Advocates of statins should be treated with scepticism
Statins have many more side-effects than has been admitted, and advocates should be treated with scepticism.
I don’t know what concrete evidence chief pharmaceutical officer Dr Keith Ridge has in claiming: ‘Hundreds of thousands of people could benefit if the industry committed more research and investment in bringing high-dose statins to the high street, and the NHS is going to be driving forward these efforts, as we save thousands of lives from deadly heart attacks and strokes as part of our long term plan’.
If increasing numbers of people without heart disease take statins, it will be a victory for vested interests over evidence.
At present, it’s estimated that six to seven million people in the UK take statins. The evidence for the benefit in primary prevention, such as preventing cardiovascular disease in people who don’t have diagnosed cardiovascular disease, is weak.
Most studies, even a large randomised controlled trial like the West of Scotland Coronary Prevention Study showed no impact on overall mortality. True, there was a reduction in incidence rates of strokes and heart attacks, but no one lived longer. Most of the data on statins is presented using a reduction in relative risks, which inflates the benefit. For example, the Heart Protection Study claimed a 40% reduction in mortality from cardiovascular disease, but the reduction in overall mortality was 0.3% per year.
Even if you accept NHS England’s advice, your chance of avoiding a ‘serious vascular event’, such as a heart attack or a stroke, is 140:1 – that is, if you’re healthy with a low risk of cardiovascular disease. On top of this, you have to keep taking the statins for five years.
Because the benefits from a reduction of risk of cardiovascular disease are so small, it becomes crucial to know your chance of suffering side-effects. Of these, myalgia has always been a particular concern. But while the evidence from trials puts this at about 1%, others, especially clinicians who see patients on a daily basis, put side effects at 18%.
This isn’t just unpleasant, it can seriously interfere with the ability to exercise, one of the prime ways of avoiding heart disease. There is also a big debate going on about statins raising the risk of diabetes. The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial revealed that one in every 100 women taking a statin risked developing type 2 diabetes at 1.9 years.
Now imagine the costs and workload of follow-up appointments and hospital investigations that patients experiencing such side-effects could incur.
With all of these in mind, I urge NHS England to reconsider its position. Instead of converting millions of people into statin users, we should all be focusing on the real factors that reduce the risk of heart disease: healthy diets, exercise and avoiding smoking.
This doesn’t mean that statins should be stopped for patients who are currently taking them and have proven benefits. It’s about statins being used appropriately, in the treatment and secondary prevention of cardiovascular disease.
Dr Kailash Chand OBE is a retired GP in Tameside