The National Institute for Health and Care Excellence has leapt to the defence of its draft guidance on statin use in response to an open letter from senior doctors who claim the move will “medicalise” five million healthy people.

The nine doctors, which include Sir Richard Thompson, president of the Royal College of Physicians, have written to NICE and health secretary Jeremy Hunt to express concern over proposed guidance from the cost watchdog that anyone with a 10% or greater risk of developing cardiovascular disease in the next 10 years should be eligible for statins. They question whether the benefits of the cholesterol-lowerers outweigh the side-effects, noting that all available data on the pills comes from pharmaceutical companies.

"The overdependence on industry data raises concerns about possible biases. Extensive evidence shows that industry-funded trials systematically produce more favourable outcomes than non-industry sponsored ones," they write. The doctors add that “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 lifelong”.

Prevent 'many lives being destroyed'

NICE responded quickly and Mark Baker, director of its Centre for Clinical Practice, said that “cardiovascular disease maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill one in three of us. Our proposals are intended to prevent many lives being destroyed”.

Final recommendations will be used next month and he noted that “our proposals are also being independently peer-reviewed to ensure they are reliable and evidence-based”. Prof Baker stressed that 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” but encourages GPs to fully explore with their patients the ways in which people can reduce their risk.

He also noted that because the price of statins has fallen, “it is also cost-effective to use them to reduce the risk of cardiovascular disease at a lower threshold than NICE has previously recommended”.

Much of the letter is devoted to an attack on the pharmaceutical sector and speaks of concerns about “true levels of adverse events, hidden data, industry bias, loss of professional confidence and conflicts of interest”. The doctors go on to say that “we are also seriously concerned that eight members of  NICE’s panel of 12 experts for its latest guidance have direct financial ties to the pharmaceutical companies that manufacture statins”.

Furthermore, some members “are also involved in next generation, more expensive, cholesterol-lowering drugs” and “we feel that parties with industry conflicts should not be participants in generating recommendations regarding drug use that will influence medical care across the population”, the doctors argue.

'Runaway train out of control'

One of the signatories, Simon Capewell, professor of clinical epidemiology at the University of Liverpool, told PharmaTimes that “the NICE statin proposals represent a runaway train out of control. It needs to be stopped””. He said that “surely NICE can better manage the conflicts of interests issues” and asked why Oxford University researchers, who have carried out many very large studies on statins, and other lipid modification agents with pharmaceutical company support, “are refusing to disclose information on side effects in individual patients?"

Prof Capewell questioned the wisdom of whether “10,000 healthy people need to take a statin for life, just to prevent one heart attack”. He added that “large studies confirm what ordinary clinicians know -  that half the patients started on statins stop them within one year, usually because of troublesome side effects. Why does NICE so casually dismiss this important evidence?"

However, Prof Baker defends the people on NICE’s independent expert committees, saying that “none of them have put their names to the recommendations to make money for themselves, as the American doctor (David Newman of Mount Sinai School of Medicine, New York) who co-signed the letter alleges”.

He concluded by saying that “concerns about hidden data and the bias that the pharmaceutical industry may or may not have are important issues and need to be resolved. 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”.

Finally, Prof Baker said it is worth noting that “other countries have looked at the same evidence and reached similar conclusions about the prescription of statins”.