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Professor who sparked statins row says government should intervene Professor who sparked statins row says government should intervene
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The Oxford professor who triggered a public row over statins says the Department of Health and other authorities should intervene to ensure the public gets accurate information on the risks and benefits of the potentially life-saving drugs.The Oxford professor who triggered a public row over statins says the Department of Health and other authorities should intervene to ensure the public gets accurate information on the risks and benefits of the potentially life-saving drugs.
Prof Sir Rory Collins said he had little confidence in an inquiry convened by the British Medical Journal (BMJ) to decide whether two papers it published that made an error on the extent of side-effects should be completely withdrawn. Prof Sir Rory Collins said he had little confidence in an inquiry convened by the British Medical Journal to decide whether two papers it published that made an error on the extent of side-effects should be completely withdrawn.
The papers published by the BMJ last year – one by John Abramson, a clinician working at Harvard medical school, and the other by Aseem Malhotra, a cardiologist in the UK – said statins did not reduce mortality and that side-effects meant they did more harm than good. The papers published by the BMJ last year were by John Abramson, a clinician working at Harvard medical school, and Aseem Malhotra, a cardiologist in the UK. Abramson said statins in low-risk patients did not reduce mortality. Both authors said that in the low-risk group the side-effects meant they sometimes did more harm than good.
The authors have retracted those statements, but Collins says as long as the papers are in circulation, they will still wrongly undermine confidence in the drugs and he does not believe the inquiry is truly independent. The authors have retracted those statements, but Collins said that as long as the papers were in circulation, they would wrongly undermine confidence in the drugs, and he did not believe the inquiry was truly independent. He said: "I don't think it is appropriate for the British Medical Journal to investigate itself," and called on the General Medical Council, the Academy of Medical Sciences or the Department of Health to investigate.
Collins said: "I don't think it is appropriate for the British Medical Journal to investigate itself," and called on the General Medical Council, the Academy of Medical Sciences or the Department of Health to investigate. He said when the BMJ "gets things wrong, it doesn't correct them properly; when it's shown it gets things wrong, it doesn't make that clear – for example blaming the peer reviewers when it wasn't the peer reviewers' fault – and they shouldn't be in a position where they are investigating themselves. That wouldn't be happening in any other sphere."
He added that when the BMJ "gets things wrong, it doesn't correct them properly; when it's shown it gets things wrong, it doesn't make that clear – for example blaming the peer reviewers when it wasn't the peer reviewers' fault – and they shouldn't be in a position where they are investigating themselves. That wouldn't be happening in any other sphere." Cholesterol-lowering statins are life-savers, helping prevent heart attacks and strokes in people who have already had one and so are at high risk of another. But the battle now raging is over the use of the drugs in healthy people at low risk.
Cholesterol-lowering statins are life-savers, helping to prevent heart attacks and strokes in people who have already experienced one and are therefore at high risk of another. But the battle now raging is over the use of the drugs in healthy people at low risk.
Draft guidance from the National Institute for Health and Care Excellence (Nice) has recommended that everybody with a risk as low as 10% over 10 years (rather than 20% as now) should be eligible for statins from their GP. About 7 million middle-aged people are now taking a daily statin and the regulator's proposed guidance could extend that to 5 million more.Draft guidance from the National Institute for Health and Care Excellence (Nice) has recommended that everybody with a risk as low as 10% over 10 years (rather than 20% as now) should be eligible for statins from their GP. About 7 million middle-aged people are now taking a daily statin and the regulator's proposed guidance could extend that to 5 million more.
This week, one of the two BMJ authors and seven other doctors, including the president of the Royal College of Physicians, Sir Richard Thompson, and a former chair of the Royal College of GPs, Dr Clare Gerada, wrote to Nice and the health secretary, Jeremy Hunt, asking for the guidance to be delayed. The letter questioned the benefits and side-effects in low-risk people and claimed the true picture was distorted because drug companies had not put trial data into the public domain.This week, one of the two BMJ authors and seven other doctors, including the president of the Royal College of Physicians, Sir Richard Thompson, and a former chair of the Royal College of GPs, Dr Clare Gerada, wrote to Nice and the health secretary, Jeremy Hunt, asking for the guidance to be delayed. The letter questioned the benefits and side-effects in low-risk people and claimed the true picture was distorted because drug companies had not put trial data into the public domain.
Thompson has declined to comment, but the British Cardiovascular Society, which represents physicians treating heart disease, said the letter he signed "does not represent the views" of its members. Thompson has declined to comment, but the British Cardiovascular Society, which represents physicians treating heart disease, said the letter he signed did not represent the views of its members.
Nice rejected the call for delay. "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," said Prof Mark Baker, director of its centre for clinical practice.Nice rejected the call for delay. "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," said Prof Mark Baker, director of its centre for clinical practice.
At the heart of the furore is a deep-seated concern on the part of some GPs and the public about putting people on pills when they are not ill. While childhood vaccination has been very widely accepted, the idea of a daily drug dose to ward off illness in adulthood disturbs many people.At the heart of the furore is a deep-seated concern on the part of some GPs and the public about putting people on pills when they are not ill. While childhood vaccination has been very widely accepted, the idea of a daily drug dose to ward off illness in adulthood disturbs many people.
The two papers published by the BMJ last year are part of a long-running campaign against this "medicalisation" of life by the journal. People who turn up in GP surgeries with raised cholesterol are often unfit rather than unwell. They have lifestyle issues, including inactivity and being overweight. Nice's guidance says doctors should support patients in changing their lifestyle first and offer statins only if they and the patient think it appropriate, but some GPs fear there will be pressure to put more people on pills.The two papers published by the BMJ last year are part of a long-running campaign against this "medicalisation" of life by the journal. People who turn up in GP surgeries with raised cholesterol are often unfit rather than unwell. They have lifestyle issues, including inactivity and being overweight. Nice's guidance says doctors should support patients in changing their lifestyle first and offer statins only if they and the patient think it appropriate, but some GPs fear there will be pressure to put more people on pills.
Gerada has said this was the main reason she signed the letter and not any suspicion of the drug companies. The statins story, she said, "is a metaphor for what is going on today – the medicalisation of humans". Gerada said this was the main reason she had signed the letter, rather than any suspicion of the drug companies. The statins story, she said, was "a metaphor for what is going on today – the medicalisation of humans".
We have, she said, "paradoxical and conflicting agendas. One is patient empowerment, putting the public and patients in charge of their health, trying to get them to self-manage, trying to get them to try to understand the consequences of what they do and trying to get them to self-care."We have, she said, "paradoxical and conflicting agendas. One is patient empowerment, putting the public and patients in charge of their health, trying to get them to self-manage, trying to get them to try to understand the consequences of what they do and trying to get them to self-care."
But on the other side was a different agenda, she said, committed to "if it can be measured, it shall be and this idea that fit, healthy people who are middle-aged and elderly shouldn't be congratulated for that. Instead we should pull them in and give them medicines, just in case."But on the other side was a different agenda, she said, committed to "if it can be measured, it shall be and this idea that fit, healthy people who are middle-aged and elderly shouldn't be congratulated for that. Instead we should pull them in and give them medicines, just in case."
A middle-aged woman, for instance, could be on a statin, aspirin, hormone-replacement therapy and possibly vitamin D. "A whole bucketload of medicines are being promoted to people and yet this is juxtaposed against the self-care agenda. And at the same time we have the fattest people, the most unhealthy people, who are taking less exercise and drinking more. So are we then being hoodwinked into thinking if we take this pill, we can abdicate responsibility for all our health needs because we've taken a pill?"A middle-aged woman, for instance, could be on a statin, aspirin, hormone-replacement therapy and possibly vitamin D. "A whole bucketload of medicines are being promoted to people and yet this is juxtaposed against the self-care agenda. And at the same time we have the fattest people, the most unhealthy people, who are taking less exercise and drinking more. So are we then being hoodwinked into thinking if we take this pill, we can abdicate responsibility for all our health needs because we've taken a pill?"
Collins said he was in favour of debate, but that it was vital that people had the facts. "I think it is perfectly reasonable that people decide not to take a statin or a doctor decides not to recommend it, but I think people should be able to make an informed choice," he said. Collins said he was in favour of debate, but that it was vital people had the facts. "I think it is perfectly reasonable that people decide not to take a statin or a doctor decides not to recommend it, but I think people should be able to make an informed choice," he said.
"I'm concerned that the public as a whole and doctors as a whole are being misinformed. The impact is likely to be greatest in the people in greatest need. I know people don't like the comparison with MMR [measles, mumps and rubella] vaccine, but the reality of this is far worse. This has the potential to cause very large numbers of unnecessary deaths from heart attacks and strokes, and the people who put their names to that letter should be ashamed of themselves. But in my view this goes to the failure of the BMJ to deal promptly with the problem when it was identified [by withdrawing the two papers].""I'm concerned that the public as a whole and doctors as a whole are being misinformed. The impact is likely to be greatest in the people in greatest need. I know people don't like the comparison with MMR [measles, mumps and rubella] vaccine, but the reality of this is far worse. This has the potential to cause very large numbers of unnecessary deaths from heart attacks and strokes, and the people who put their names to that letter should be ashamed of themselves. But in my view this goes to the failure of the BMJ to deal promptly with the problem when it was identified [by withdrawing the two papers]."
Fiona Godlee, editor of the BMJ, believes it has behaved entirely properly. Collins criticised her appointment of Dr Iona Heath, chair of the BMJ's ethics board but also author of a paper critical of statins some years ago, to head the inquiry. "I needed to make a decision quickly and Iona is someone of enormous integrity who knows how the BMJ works," she said. The decision will be made by the others on the panel and "will have to be very firmly justified", she said. All the evidence will be put in the public domain. The journal will continue to explore the issues around medicalisation, she has said. Fiona Godlee, editor of the BMJ, said she believed it had behaved entirely properly. Collins criticised her appointment of Iona Heath, chair of the BMJ's ethics board but also the author of a paper critical of statins some years ago, to head the inquiry. "I needed to make a decision quickly and Iona is someone of enormous integrity who knows how the BMJ works,"Godlee said. The decision would be made by the others on the panel and "will have to be very firmly justified", she added. All the evidence will be put in the public domain, and she has said the journal will continue to explore the issues around medicalisation.
Collins and his team at Oxford University's clinical trials service unit are the only investigators who have seen the full patient-level data for some – but not all – of the statins trials. They formed the Cholesterol Treatment Trialists Collaboration in order to monitor and analyse the data on statins over the years. His critics point out that drug companies have helped fund his work. Collins and his team at Oxford University's clinical trials service unit are the only investigators who have seen the full patient-level data for some – but not all – of the statins trials. They formed the Cholesterol Treatment Trialists Collaboration to monitor and analyse statins data over the years. His critics point out that drug companies have helped fund his work.
Shah Ebrahim, however, who heads the independent Cochrane Collaboration team whose review of the benefits and side-effects of the drugs led to the Nice recommendation, also thinks the papers should be withdrawn. "I have not taken money from the pharmaceutical companies. I don't get aeroplane tickets paid for by pharmaceutical companies to speak at meetings. I'm coming at it untarnished of influence," he said. Shah Ebrahim, head of the independent Cochrane Collaboration team, whose review of the benefits and side-effects of the drugs led to the Nice recommendation, also thinks the papers should be withdrawn. "I have not taken money from the pharmaceutical companies. I don't get aeroplane tickets paid for by pharmaceutical companies to speak at meetings. I'm coming at it untarnished of influence," he said.
"I was a statins sceptic three years ago. Our second Cochrane review reflected that in our cautious interpretation of what should be done." But over the past couple of years, he has changed his mind and is dismayed at the selective use of data and single studies to discredit the drugs."I was a statins sceptic three years ago. Our second Cochrane review reflected that in our cautious interpretation of what should be done." But over the past couple of years, he has changed his mind and is dismayed at the selective use of data and single studies to discredit the drugs.
"An awful lot of loose statistics have been bandied about," he said. The paper by Abramson and colleagues in the BMJ, he said, "was a pitch to discredit Rory Collins's analysis and the Cochrane review. We wrote and said they have got the sums wrong and the side-effects data was spurious. They have now withdrawn that.""An awful lot of loose statistics have been bandied about," he said. The paper by Abramson and colleagues in the BMJ, he said, "was a pitch to discredit Rory Collins's analysis and the Cochrane review. We wrote and said they have got the sums wrong and the side-effects data was spurious. They have now withdrawn that."
Ebrahim has recently published a major review not only of the side-effects data in the published trials, but also of 90 "observational studies" – the side-effects reports from real people taking statins over the years – which is not data owned by secretive drug companies. The paper, in Biomed Central, found that the absolute risk of harmful unintended events of statins was "very small" compared with the benefits.Ebrahim has recently published a major review not only of the side-effects data in the published trials, but also of 90 "observational studies" – the side-effects reports from real people taking statins over the years – which is not data owned by secretive drug companies. The paper, in Biomed Central, found that the absolute risk of harmful unintended events of statins was "very small" compared with the benefits.
The most serious was "weak evidence" of an increase in type-2 diabetes in a small proportion of people on statins. "That does seem to be real, but it seems to be a feature of people who have risk factors for diabetes," he said. It was possible that the statins caused the diabetes to develop earlier – but the drug would still help prevent a heart attack that might kill them, he said.The most serious was "weak evidence" of an increase in type-2 diabetes in a small proportion of people on statins. "That does seem to be real, but it seems to be a feature of people who have risk factors for diabetes," he said. It was possible that the statins caused the diabetes to develop earlier – but the drug would still help prevent a heart attack that might kill them, he said.
Much of the controversy concerns low levels of side-effects. Some people on statins complain of tiredness or muscle pain. But in the drug trials, so did roughly equal numbers of people unwittingly taking placebos – dummy pills. "Potentially 17% of people give up taking a statin and 17% give up taking a placebo. That is the nature of tablet taking," said Ebrahim. Sometimes there may be a "nocebo effect" – people experience aches and pains in middle age that they may attribute to a drug they are taking. But sometimes, they just don't want to be on pills. And curiously, that is exactly the argument of the anti-medicalisation lobby. Much of the controversy concerns low levels of side-effects. Some people on statins complain of tiredness or muscle pain. But in the drug trials, so did roughly equal numbers of people unwittingly taking placebos. "Potentially 17% of people give up taking a statin and 17% give up taking a placebo. That is the nature of tablet taking," said Ebrahim.
Sometimes there may be a "nocebo effect" – people experience aches and pains in middle age that they may attribute to a drug they are taking. But sometimes, they just don't want to be on pills. And curiously, that is exactly the argument of the anti-medicalisation lobby.