A letter sent to NICE chairman Professor David Haslam and health secretary Jeremy Hunt on Tuesday was signed by leading GPs including Professor Clare Gerada, former RCGP chairwoman, Dr Malcolm Kendrick from the GPC and Hertfordshire GP Professor David Haslam, chair of the National Obesity Forum.
They called on NICE to halt its bid to push through guidance this summer that would recommend GPs offer preventive statin treatment to patients with a 10% or over 10-year risk of cardiovascular disease - half the level that currently used to steer treatment.
The signatories, including Sir Richard Thompson, president of the Royal College of Physicians, said the benefits of statins in a low-risk population do not justify life-long use of the drugs by an estimated five million additional patients.
They expressed concerns about 'worrying anomalies' in the levels of adverse events reported in major statin trials. These have shown inconsistent levels of adverse effects in the placebo arms of the studies, ranging from 2.7% to 80.4%, yet adverse effect rate of statins was in each trial 'always very similar to that of placebo', they said.
'Without access to the raw data, it is difficult to understand how statin-related adverse events, and placebo-related adverse events can mirror each other so precisely, whilst the absolute rates can vary thirty-fold (almost 3,000%). These data most certainly require analysis by a third party with appropriate expertise,' the doctors wrote.
The letter said it was 'a further serious concern' that the data used by NICE to formulate its guidance on statins comes 'almost entirely' from studies funded by the pharmaceutical industry. Industry-funded trials tend to produce more favourable outcomes than non-industry funded ones, they said, and participants may not represent real-world populations.
The doctors said: 'To conclude, we urge you to withdraw the current guidance on statins for people at low risk of cardiovascular disease until all the data are made available. The potential consequences of not doing so are worrying: harm to many patients over many years, and the loss of public and professional faith in NICE as an independent assessor. Public interests need always to be put before other interests, particularly Pharma.'
Responding to the letter, Professor Mark Baker, director of the Centre for Clinical Practice at NICE, rejected the call and said the guidance was intended 'to prevent many lives being destroyed'.
The draft guideline did not propose that statins should be used instead of the lifestyle changes such as stopping smoking or being more active, he said. 'It encourages GPs to fully explore with their patients the ways in which people can reduce their risk of cardiovascular disease, presenting all the options promoted by the draft guidance, including lifestyle changes, BP control, avoidance of diabetes and cholesterol lowering, and to allow patients to make their own decisions.'
'No credible argument'
He added that NICE's independent expert committee found that evidence showed there was 'no credible argument' against the safety and clinical effectiveness of statins in patients with a 10% risk of disease over 10 years, and falling prices meant it was cost-effective to intervene at lower levels of risk.
Professor Baker said: 'This guidance does not medicalise millions of healthy people. On the contrary, it will help prevent many from becoming ill and dying prematurely.'
The letter comes just days after the MHRA insisted the overall benefits of statins continued to outweigh risks.