Researchers question ‘bias’ NICE on statins
pharmafile | June 11, 2014 | News story | Sales and Marketing | Drug pricing, Haslam, NHS, NICE, statins
Doctors are warning that NICE’s desire to increase prescriptions of statins in England is based on pharma-funded research that ignores their potentially dangerous side effects.
Writing to both ministers and to the chairman of NICE – Professor David Haslam – senior British doctors argue that the draft advice was overly reliant on industry-sponsored trials, which ‘grossly underestimate adverse effects’, which can include increasing the risk of type 2 diabetes.
The letter adds: “The benefits in a low-risk population do not justify putting approximately five million more people on drugs that will then have to be taken life-long.”
The nine signatories include Royal College of Physicians president Sir Richard Thompson and former Royal College of GPs chairwoman Clare Gerada, as well as a number of cardiologists and leading academics.
Currently, doctors are meant to offer statins to the estimated seven million people who have a 20% chance of developing cardiovascular disease over 10 years, based on risk factors such as their age, sex, whether they smoke and their weight.
But NICE’s most recent draft guidance published in February, notes that people with as low as a 10% risk should be offered the treatment, possibly increasing the number of people taking these drugs by five million.
There has been a long-running debate for years over the potential side effects of statins, and the BMJ was recently forced to withdraw claims over the extent of the side effects of these medicines for one of its journal articles.
NICE responds
Professor Mark Baker, director of the Centre for Clinical Practice at NICE, says: “The draft guideline does not propose that statins should be used instead of the lifestyle adjustments that people at risk of cardiovascular disease need to make – such as stopping smoking, being more active, drinking less alcohol, eating more healthily and losing weight.”
The reason NICE has increased its use of statins is because the price of these drugs have fallen due to several patent expiries, including Pfizer’s Lipitor (atorvastatin), meaning they have now become more cost-effective at a lower threshold than NICE has previously recommended.
“NICE guidance is developed by independent expert committees,” Baker goes on. “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. None of them have put their names to the recommendations to make money for themselves, as the American doctor, who co-signed the letter alleges.
“It is impossible to put together credible clinical practice guidance without drawing on the knowledge of those who understand and work with the drugs and other treatments involved.”
He says that concerns about hidden data and the bias that the pharmaceutical industry may or may not have are ‘important issues’ that ‘need to be resolved’. It has gone some way to show this by signing the AllTrials register last year, a group that is pushing for greater clinical trial transparency.
“NICE is part of the effort to do that but just as the signatories to the letter will have done in their professional careers, we need to act in the best interests of patients on the basis of what we know now,” Baker says.
“Finally, it’s worth noting that other countries have looked at the same evidence and reached similar conclusions about the prescription of statins.”
Ben Adams
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