False claims about the risks of statins may have cost the lives of tens of thousands of Britons, researchers have said, after a Lancet study found the drugs do not cause side-effects which have deterred many.
The research on 10,000 people found that if they did not know what drugs they were given, they were no more likely than those given sugar pills to report symptoms such as muscle pain, sleep disturbance and cognitive impairment.
Yet when participants in a second part of the trial were told the drugs were statins, rates of some reported side-effects shot up – with muscle pain appearing up to 41 per cent more common.
Last night the study’s lead author accused British medicines regulators of “jumping the gun” in ever listing such side-effects on drug packaging.
Prof Peter Sever, from Imperial College London, urged the Medicines and Healthcare Products Regulatory Agency (MHRA) to now strip packets of such warnings, in order to save “tens if not hundreds of thousands of lives”.
There are people out there who are dying because they’re not taking statins, and the numbers are large, the numbers are tens of thousands, if not hundreds of thousandsProf Peter Sever, Imperial College London
He said it was a “tragedy” akin to the MMR scandal that high risk patients had been deterred from taking drugs which could save their lives. Urging patients not to “gamble” with the risk of heart attacks and strokes, he said “bad science” had misled the public, deterring many from taking life-saving medication.
The study of patients at risk of heart disease, found that those told that their daily drug was a statin were far more likely to think they were suffering side-effects.
Researchers said it illustrated a “nocebo effect” which meant patients were more likely to think they were experiencing side-effects if they expected them.
As a result, daily aches and pains were more likely to be attributed to statins.
The phenomenon is the opposite to the well-known placebo effect, the beneficial response sometimes experienced by those given “dummy” drugs as part of trials.
NHS guidance recommends the cholesterol-busting drugs for around 40 per cent of adults.
But a number of doctors have argued against “mass medicalisation” saying too many pills are being doled out instead of efforts to improve lifestyles.
The new study suggests millions of patients could benefit from high doses of statins
Prof Sever said many of those arguing against statins had exagerrated risks such as muscle pain, which were not backed by the new study, the largest ever research into their side-effects.
In 2009, the MHRA listed such side-effects on packaging for statins, after a series of observational studies suggested such links.
Prof Sever said the regulator should never have taken such action.
“There are people out there who are dying because they’re not taking statins, and the numbers are large, the numbers are tens of thousands, if not hundreds of thousands. And they are dying because of a nocebo effect, in my opinion,” he said.
“Many of us would say that the MHRA … did not make a profound value judgment based on the evidence,” the professor said.
“We would hope that the MHRA will withdraw that request that these side effects should be listed.”
He added: “These warnings should not be on the label … I would love to see these side effects removed.
A spokesman for the MHRA said: “The benefits of statins are well established and are considered to outweigh the risk of side-effects in the majority of patients.”
“Any new significant information on the efficacy or safety of statins will be carefully reviewed and action will be taken if required, including updates to product labelling.”
The study’s researchers said statins were not without any side-effects. Statins carry around a 9 per cent increased risk of diabetes, they said, with links to uncommon side effects such as myopathy, resulting in muscle weakness.
Even so, the benefits of the drugs in reducing risk of heart attacks and strokes “overwhelmed” the risk of side-effects, Prof Sever said.
Speaking of the nocebo effect, he said: “Just as the placebo effect can be very strong, so too can the nocebo effect.
“This is not a case of people making up symptoms, or that the symptoms are ‘all in their heads’. Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm.”
The study was funded by drug company Pfizer, which makes statins, but the authors said all data collection, analysis and interpretation of the results was carried out independently.
London cardiologist Dr Aseem Malhotra, who has argued against mass prescribing of statins, last night insisted the drugs had only “marginal” benefits for those with established heart disease, and did not save lives for lower risk patients.
Other research had found that more than half of patients put on statins abandoned them within a year, most commonly because of side-effects, he said.
He said the misrepresentation of the risks and benefits of statins would unfold to become “one of the biggest scandals in the history of medicine”.