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Cardiovascular agents

NICE urged to revise draft guidance on statins

Doctors have written to the National Institute for Health and Care Excellence to highlight concerns over proposed statin recommendations

Doctors and researchers are urging the National Institute for Health and Care Excellence to withdraw its draft guidance on statins for people at low risk of cardiovascular disease (CVD).

The draft guidance, published in February 2014, recommends offering statin treatment to people who have a 10% or greater 10-year risk of developing CVD, cutting the threshold by half.

In an open letter to NICE, copied to health secretary Jeremy Hunt, a group of leading doctors highlight their concerns on six issues: medicalisation of healthy individuals; true levels of adverse events; hidden data; industry bias, loss of professional confidence and conflicts of interest.

They say the data on which the NICE guidance is based are derived almost entirely from pharmaceutical company funded studies, which are not available for review by independent researchers.

According to the letter, 8 members of NICE’s panel of 12 experts for the draft guidance have direct financial ties to the pharmaceutical companies that manufacture statins.

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Source: Design56/Dreamstime.com

Most statins are now available as generics

However, Helen Williams, consultant pharmacist for cardiovascular disease at NHS Southwark Clinical Commissioning Group, points out that the majority of statins are now available generically, including the specific agent proposed for use by NICE, so there is little to be gained by any of the big pharmaceutical firms from the proposed guideline changes.

Mark Baker, director of the centre for clinical practice at NICE, stresses that NICE guidance is developed by independent expert committees. “They review all of the available evidence and their conclusions are subject to genuine public consultation.” The committees are made up of clinicians, patients and others with the skills necessary to help interpret sometimes complex data, he says, adding that “none of them have put their names to the recommendations to make money for themselves”.

Williams believes that the debate on statin therapy, which is being held in the media spotlight, will be causing significant concern to patients currently on statins, or those being offered statin treatment. She stresses the importance of distinguishing between primary prevention of cardiovascular disease — which is the focus of this debate — and secondary prevention of CVD,  in which there is no doubt over the benefits of statin therapy.

“It is essential, therefore, that all patients with established CVD receive clear messages from pharmacists and other healthcare professionals about the importance of continuing with their statin treatment; and where they are experiencing side effects that these are dealt with effectively, through prescribing an alternative statin, reducing the dose or changing the time of administration,” says Williams.

Final guidance by NICE is due to be published in July 2014. “It will be interesting to see whether this external and very public lobbying will have an impact on this schedule or its final recommendations,” says Williams.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065347

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