Plans to prescribe statins to millions more people must be put on hold, a group of leading doctors have said, in a highly critical letter which accuses the Government’s respected health standards body of “conflicts of interest”.
The letter, signed by nine doctors and academics including the president of the Royal College of Physicians (RCP), warns “public and professional faith” in the National Institute for Health and Care Excellence (NICE) could be lost and harm could be done to “many patients over many years”.
It accuses the standards body of seeking to “medicalise five million healthy individuals”.
The criticisms come after NICE issued draft guidance earlier this year recommending that cholesterol-lowering statins should be prescribed to all patients with at least a 10 per cent risk of heart attack or stroke in the next 10 years.
In their letter, the doctors said they were “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”. They also warn that “overdependence on industry data raises concerns about possible biases”.
Statins – taken by seven million people in the UK – are recommended for patients with a 20 per cent risk of cardiovascular disease in the next 10 years. While their benefits at cutting heart attack and stroke risk are not disputed, it has been claimed that industry-led studies had under-estimated the extent of statins’ side effects. Some doctors fear in otherwise healthy individuals, the drugs may do more harm than good.
The doctors want the new guidance withdrawn until all data from statins’ trials is made available to “credible researchers”. In response to the criticisms, NICE said there was “no credible argument against [statins’] safety and clinical effectiveness” for patients with a 10 per cent risk.
Professor Mark Baker, director of NICE’s centre for clinical practice, added: “Our approach is transparent, rigorous and sensible… Concerns about hidden data and bias 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... we need to act in the best interests of patients on the basis of what we know now.”
What are the concerns around statins?
There are no major concerns about statins themselves – it is more a question of who should be taking them. New draft guidance from NICE proposes to significantly lower the ‘treatment threshold’ so that millions more people at a lower risk of heart attack or stroke would be given them.
Why would that be a problem?
Many experts say it wouldn’t, and would save lives. But others say that NICE is recommending statins for patients who have such low risk, that it would be unnecessary and expensive to give them statins, and the only beneficiaries would be the pharmaceutical companies that make the drugs.
What about the side effects?
Like all drugs statins have some side effects, but in high risk patients these are negligible compared to their benefits in cutting the chances of heart disease. But some studies have shown higher rates of the side effects – including muscle pain and increased likelihood of diabetes – and many doctors argue these could outweigh the small benefits that taking a statin would achieve for low risk patients.
Why is there no scientific consensus based on the evidence?
Some of the key findings on statins effectiveness and side effects comes from industry-funded studies. There is also a great deal of data which has not been made available for all researchers to see. Many doctors have argued that NICE should not make recommendations until all the data on statins is made available to all researchers.
Should I carry on taking my statins?
Absolutely, yes. The current guidance, under which you will have been prescribed a statin, is not disputed.