An Oxford professor is to lead an extensive review into the side effects of the cholesterol-lowering drugs statins.
Sir Rory Collins, co-director of the University’s Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), and his Oxford colleagues will re-examine the medical records of tens of thousands of patients included in previous studies into the widely prescribed drug.
The new review will assess the prevalence of various reported side effects, such as muscular pain, diabetes, and memory loss.
The editor of the British Medical Journal (BMJ) Dr. Fiona Godlee commented, “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.”
Last July, the National Institute for Health and Care Excellence (NICE) published new guidelines on statins, with doctors instructed to prescribe statins to patients deemed to be at a ten per cent risk of a heart attack in the next decade, if lifestyle changes are unsuccessful at bringing down the risk.
Prior to the release of the latest guidance, NICE had recommended that statins should only be prescribed to individuals with a 20 per cent risk of heart attack in the next ten years.
The new instructions, based on what NICE described as the “best and most complete review of evidence in this field”, mean that up to 40 per cent of the adult population are eligible to be prescribed statins.
Conservative MP Dr. Sarah Wollaston, chairwoman of the House of Commons’ Health Select Committee, said, “I’m concerned there may be side effects that have not been reported. Drug manufacturers should release all their trial data on statins so they are available for scrutiny.”
Oxford’s Visiting Professor of Public Health Epidemiology Dr. Klim McPherson 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.”
Statins are a group of drugs that lower blood cholesterol levels by limiting the build-up of fatty deposits in the arteries, which can cause cardiovascular conditions.
Cardiovascular disease (CVD) is the biggest killer in England and Wales, constituting nearly a third of deaths each year and having cost the NHS an estimated £7.88bn in 2010.
NICE has argued that if all eligible patients were offered statins, as many as 28,000 heart attacks and 16,000 strokes could be prevented each year.
Nonetheless, this has been met with fears of the influence of pharmaceutical companies and unnecessary ‘medicalisation’.