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'Nocebo' turns Brits off cholesterol drugs

Press Association logoPress Association 3/05/2017

Thousands of Britons are dying from heart attacks and strokes after being scared away from cholesterol-lowering drugs by warnings of non-existent side effects, the lead author of a major study claims.

An investigation into statins has demonstrated aching muscles and other reported symptoms could not be blamed on the drugs.

The study, which involved about 10,000 patients at risk of heart and artery disease, highlighted a "nocebo effect" - the opposite of the placebo effect.

Warnings of common side effects listed on statin information leaflets were giving rise to nocebo symptoms despite having no provable connection with the drugs, researchers found.

Professor at Imperial College London and co-author of the study, Peter Sever, said reports of side effects had led to a fall in the number of patients taking statins and a reluctance among some doctors to prescribe them.

"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," he said.

"And they are dying because of a nocebo effect, in my opinion."

The study, published in The Lancet medical journal, was conducted in two phases, the first of which included 10,180 patients aged 40 to 79 from the UK, the Irish Republic and Scandinavia.

Patients in the first trial were "blinded" so neither they nor doctors knew who was receiving the active drug.

The study found rates of muscle-related symptoms were similar whether or not patients received the statin or placebo.

Subsequently when patients knew they were taking statins, reports of muscle-related side effects were 41 per cent more common among those being treated.

Prof Sever was highly critical of the Medicines and Healthcare products Regulatory Agency (MHRA) for "jumping the gun" by insisting on the side effect warnings in 2009.

"Many of us would say that the MHRA ... did not make a profound value judgment based on the evidence," Prof Sever said, adding the agency had acted on observational reports not based on robust science.

"These warnings should not be on the label ... I would love to see these side effects removed."

The study was funded by drug company Pfizer, which makes statins, but the authors stressed all data collection, analysis and interpretation of the results was carried out independently.

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