BMJ 2014;349:g4380 doi: 10.1136/bmj.g4380 (Published 1 July 2014)
Page 1 of 2
News
NEWS Six professors back NICE guidance on extending use of statins Nigel Hawkes London
The so called statins war triggered by two papers in The BMJ1 2 and new guidance from the UK National Institute for Health and Care Excellence (NICE) recommending wider use of the drugs shows no signs yet of a ceasefire.
already going on. “But the critics are wrong,” he said. “They’ve retracted, they’re wrong.”
The Oxford University academic Rory Collins, head of the CTT (cholesterol treatment triallists) group, said that the authors of the two papers in The BMJ had withdrawn their claim that 18-20% of statin users experienced side effects. But they had not withdrawn a claim that 5% of users have myopathy. “Actually it’s 100 times less,” he said. He had earlier called for a full retraction of the papers and criticised The BMJ’s appointment of a panel chaired by Iona Heath, former president of the Royal College of General Practitioners, to decide whether that demand should be met.
He and Collins denied that there were any data on side effects that had not been published. The Clinical Trial Service Unit at Oxford, which Collins runs, holds a database of statin trial data that includes details of major vascular events, cause specific mortality, and site specific cancer but excluding muscle aching and myopathy, which were never sought. When asked about the patient level data, Collins said, “We don’t have all of the adverse events data from all of the trials.” However, Weissberg insisted that all these data had been published by the original triallists and were available.
At a press briefing in London organised by the Science Media Centre, six leading professors of cardiology and epidemiology stated their conviction that the evidence from trials amply justified their confidence that the benefits of statins outweighed any risks. The authors of the two papers in The BMJ had been wrong, they said, and NICE had been right to suggest that statins should be offered to patients who didn’t have a high risk of cardiovascular events.
When asked after the meeting to comment on Collins’s allegation, John Abramson, lead author of one of the two papers in The BMJ, said, “In our article we correctly quoted the rate of 0.5 per 1000 users with myopathy as defined by the CTT collaborators (muscle symptoms and creatinine kinase elevations >10 times the upper limit of normal). We also quoted data from the US National Health and Nutrition Examination Survey (NHANES) for 1999-2002, which show that muscle symptoms occur in 22% of statin users and in 16.7% of non-statin users (multivariable adjusted odds ratio for any musculoskeletal pain of 1.50 (95% confidence interval 1.07 to 2.11; P=0.01)). Rather than the much higher threshold of myopathy used by the CTT Collaborators, the NHANES data show the incidence of real symptoms in real people outside the context of clinical trials.” Speaking at the press briefing, Collins said, “My main concern is about the effect that misrepresenting the evidence will have on people who are at high risk of cardiac events,” he said. “It’s perfectly reasonable to debate whether patients at lower risk should get statins or not, but it’s inappropriate to misrepresent the evidence.” Asked whether the panel members, all strong supporters of statins, would be prepared to debate the issue with others who were more sceptical, Peter Weissberg, medical director of the British Heart Foundation, said such a debate was For personal use only: See rights and reprints http://www.bmj.com/permissions
He agreed that some patients who took statins complained of side effects such as fatigue or muscle pain, but the randomised controlled trials that formed the evidence base had shown that just as many people taking a placebo made such complaints. They weren’t imagining it, the pain was real, but the fact that it was caused just as often by placebo as by statins in the trials showed that it was not an argument against statin use. “I have patients with side effects they attribute to statins,” he said. “I say, ‘Fine, stop taking the statin,’ and in most cases they come back later and say the effect is just the same.”
Weissberg said that one of the strengths of the evidence base on statins was that most trials had in fact been done by academics, funded by drug companies, among others. He said that this gave them greater credibility than trials directly conducted by the industry. “The biggest threat to good medicine is prejudice and anecdote,” he said. “We need objective evidence from RCTs [randomised controlled trials]. That is particularly important with a drug such as a statin, where we have to strike a balance between visible harm and invisible benefit.” Although all six panellists defended NICE’s guidance on extending statins to many more people at lower cardiovascular risk, they also emphasised that it was guidance and not mandatory. “We’re not forcing tablets down people’s throats,” said George Davey Smith of the University of Bristol. Collins said, “It’s a choice. The evidence is substantial, but it remains the choice of the patient. But they can only make that choice so long as they’re not misinformed.” He criticised Richard Thompson, president of the Royal College of Physicians, who was one of a group that had written to England’s health secretary and NICE opposing the guidance, saying that Thompson had later corrected statements made in the letter.
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BMJ 2014;349:g4380 doi: 10.1136/bmj.g4380 (Published 1 July 2014)
Page 2 of 2
NEWS
Fiona Fox, director of the Science Media Centre, defended her decision to invite only pro-statin experts to the briefing. The “vast majority” of cardiac and statin experts believed that the evidence was overwhelming, she said, and it was not the centre’s job to provide a platform to a minority who did not and thereby project a false image that the debate was in equipoise when it was not, she added.
For personal use only: See rights and reprints http://www.bmj.com/permissions
1 2
Abramson JD, Rosenberg H, Jewell N, Wright J. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123. Malhotra A. Saturated fat is not the major issue. BMJ 2013;3476:f6340.
Cite this as: BMJ 2014;349:g4380 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
Copyright of BMJ: British Medical Journal is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Page 1 of 2
News
NEWS Six professors back NICE guidance on extending use of statins Nigel Hawkes London
The so called statins war triggered by two papers in The BMJ1 2 and new guidance from the UK National Institute for Health and Care Excellence (NICE) recommending wider use of the drugs shows no signs yet of a ceasefire.
already going on. “But the critics are wrong,” he said. “They’ve retracted, they’re wrong.”
The Oxford University academic Rory Collins, head of the CTT (cholesterol treatment triallists) group, said that the authors of the two papers in The BMJ had withdrawn their claim that 18-20% of statin users experienced side effects. But they had not withdrawn a claim that 5% of users have myopathy. “Actually it’s 100 times less,” he said. He had earlier called for a full retraction of the papers and criticised The BMJ’s appointment of a panel chaired by Iona Heath, former president of the Royal College of General Practitioners, to decide whether that demand should be met.
He and Collins denied that there were any data on side effects that had not been published. The Clinical Trial Service Unit at Oxford, which Collins runs, holds a database of statin trial data that includes details of major vascular events, cause specific mortality, and site specific cancer but excluding muscle aching and myopathy, which were never sought. When asked about the patient level data, Collins said, “We don’t have all of the adverse events data from all of the trials.” However, Weissberg insisted that all these data had been published by the original triallists and were available.
At a press briefing in London organised by the Science Media Centre, six leading professors of cardiology and epidemiology stated their conviction that the evidence from trials amply justified their confidence that the benefits of statins outweighed any risks. The authors of the two papers in The BMJ had been wrong, they said, and NICE had been right to suggest that statins should be offered to patients who didn’t have a high risk of cardiovascular events.
When asked after the meeting to comment on Collins’s allegation, John Abramson, lead author of one of the two papers in The BMJ, said, “In our article we correctly quoted the rate of 0.5 per 1000 users with myopathy as defined by the CTT collaborators (muscle symptoms and creatinine kinase elevations >10 times the upper limit of normal). We also quoted data from the US National Health and Nutrition Examination Survey (NHANES) for 1999-2002, which show that muscle symptoms occur in 22% of statin users and in 16.7% of non-statin users (multivariable adjusted odds ratio for any musculoskeletal pain of 1.50 (95% confidence interval 1.07 to 2.11; P=0.01)). Rather than the much higher threshold of myopathy used by the CTT Collaborators, the NHANES data show the incidence of real symptoms in real people outside the context of clinical trials.” Speaking at the press briefing, Collins said, “My main concern is about the effect that misrepresenting the evidence will have on people who are at high risk of cardiac events,” he said. “It’s perfectly reasonable to debate whether patients at lower risk should get statins or not, but it’s inappropriate to misrepresent the evidence.” Asked whether the panel members, all strong supporters of statins, would be prepared to debate the issue with others who were more sceptical, Peter Weissberg, medical director of the British Heart Foundation, said such a debate was For personal use only: See rights and reprints http://www.bmj.com/permissions
He agreed that some patients who took statins complained of side effects such as fatigue or muscle pain, but the randomised controlled trials that formed the evidence base had shown that just as many people taking a placebo made such complaints. They weren’t imagining it, the pain was real, but the fact that it was caused just as often by placebo as by statins in the trials showed that it was not an argument against statin use. “I have patients with side effects they attribute to statins,” he said. “I say, ‘Fine, stop taking the statin,’ and in most cases they come back later and say the effect is just the same.”
Weissberg said that one of the strengths of the evidence base on statins was that most trials had in fact been done by academics, funded by drug companies, among others. He said that this gave them greater credibility than trials directly conducted by the industry. “The biggest threat to good medicine is prejudice and anecdote,” he said. “We need objective evidence from RCTs [randomised controlled trials]. That is particularly important with a drug such as a statin, where we have to strike a balance between visible harm and invisible benefit.” Although all six panellists defended NICE’s guidance on extending statins to many more people at lower cardiovascular risk, they also emphasised that it was guidance and not mandatory. “We’re not forcing tablets down people’s throats,” said George Davey Smith of the University of Bristol. Collins said, “It’s a choice. The evidence is substantial, but it remains the choice of the patient. But they can only make that choice so long as they’re not misinformed.” He criticised Richard Thompson, president of the Royal College of Physicians, who was one of a group that had written to England’s health secretary and NICE opposing the guidance, saying that Thompson had later corrected statements made in the letter.
Subscribe: http://www.bmj.com/subscribe
BMJ 2014;349:g4380 doi: 10.1136/bmj.g4380 (Published 1 July 2014)
Page 2 of 2
NEWS
Fiona Fox, director of the Science Media Centre, defended her decision to invite only pro-statin experts to the briefing. The “vast majority” of cardiac and statin experts believed that the evidence was overwhelming, she said, and it was not the centre’s job to provide a platform to a minority who did not and thereby project a false image that the debate was in equipoise when it was not, she added.
For personal use only: See rights and reprints http://www.bmj.com/permissions
1 2
Abramson JD, Rosenberg H, Jewell N, Wright J. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123. Malhotra A. Saturated fat is not the major issue. BMJ 2013;3476:f6340.
Cite this as: BMJ 2014;349:g4380 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
Copyright of BMJ: British Medical Journal is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
