Day: 09/12/2016

Care for people dying in hospitals: the data behind the audit results

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A new audit on the provision of palliative care in hospitals has found significant variations in the standard of care in hospitals across England. Get the data behind the results

Around half of all deaths in England happen in hospitals
Around half of all deaths in England happen in hospitals, according to the ONS. 

There is a “significant variation in the standard of care for people dying in hospitals” across England, according to the results of a new audit which calls for ‘widescale improvements’ in end of life care.

Health Editor, Sarah Boseley writes:

Fewer than half of NHS patients who were in their last hours or days were told that they were dying by hospital staff, according to a critical report from the Royal College of Physicians (RCP), while a significant number of families and relatives are left feeling they have no emotional support.

The report also highlights the continued lack of specialist palliative care at weekends, 10 years on from Nice recommendations that it should be offered seven days a week.

While every patient has different needs, and some will need more pain relief than others for example, there should be no variation in the quality and provision of services, or training in the care of people dying in hospitals. The audit shows that major improvements need to be made to ensure better care for dying people, and better support for their families, carers, friends and those important to them.

Around half of all deaths in England happen in hospitals according to the Office for National Statistics (ONS). The audit found that despite longstanding national recommendations from the National Institute for Health and Care excellence (Nice), only 21% of hospital sites had access to face-to-face palliative care services seven days per week. 73% provided face-to-face palliative care services on weekdays.

Only 28% of trusts had systems in place for mandatory training for nurses in care of the dying and only 19% for doctors. The audit recorded that 82% of trusts provided some form of training in the previous year, while 18% had not provided any. Almost half (47%) of Trusts did not have a named board member with responsibility for care of the dying.

It also found that 87% of patients had documented recognition that they were in the last hours or days of life, but discussion with patients was only documented in only less than half (46%) of those thought capable of discussing this. Communication with families and friends was recorded in 93% of cases and on average, these discussions occurred 31 hours prior to death.

27% of the participating trusts undertook a local survey of bereaved relatives: of those completing the questionnaire, 76% reported being very or fairly involved in decisions about care and treatment of their family member. Almost a quarter, however, did not feel they were involved in decisions at all.

63% of respondents said that the overall level of emotional support given to them by the healthcare team was good or excellent, while 37% thought it was fair or poor. Overall, 76% said they felt adequately supported during the patient’s last two days of life, almost a quarter did not.

Other key findings from the audit are below:

  • Only 21% of patients capable of having the conversation were asked about their spiritual needs, and only 25% of relatives/carers asked about their own needs
  • Most patients (63-81%) had medication prescribed ‘as required’ for the five key symptoms often experienced near the end of life: pain, agitation, noisy breathing, difficulty in breathing, nausea and vomiting. Not all patients need the medication and in the last 24 hours of life 44% received pain relief and 17% medication for shortness of breath
  • 59% of patients were clinically assessed to see if they needed artificial hydration, but discussions with the patient was only recorded with 17% of patients capable of discussing it. The situation was discussed with more than twice as many (36%) relatives and friends. Artificial hydration was in place for 29% of patients at the time of death
  • 45% of patients were clinically assessed to see if they needed artificial nutrition, but discussions with the patient was only recorded with 17% of patients capable of having the conversation. The situation was discussed with 29% of relatives and friend. Artificial nutrition was in place for 7% of patients at the time of death
  • Only 47% of Trusts reported having a formal structured process in place to capture the views of bereaved relatives or friends prior to this audit

What did the audit assess?

The new audit evaluated:

  • The quality of care received directly by 6,580 people who died in 149 hospitals in England between 1 May and 31 May 2013. This was done by reviewing the case notes of a sample of patients and is not the total number of people who died in hospital during this time. The audit only covered expected deaths
  • Results from questionnaires completed by 858 bereaved relatives or friends, asking about the treatment of their relative, their involvement in decision making, and the support available to them. The questionnaire was distributed by some hospitals involved in the audit, and the results were aggregated nationally
  • The organisation of care including availability of palliative care services, numbers of staff, training, and responsibilities for care.

The table below shows the results of only three of the clinical audit key performance indicators (KPIs) used in the NCDAH audit. You can see the information by hospital trust, they are listed in alphabetical order. You can find full table of the results including both clinical and organisational KPIs results by hospital trust in the downloadable spreadsheet.

End of life care requires ‘widescale improvements’, report says

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Royal College of Physicians investigation shows palliative care differs across hospitals with few trusts offering adequate training
NHS end of life care
The report highlights the continued lack of specialist palliative care at weekends, ten years on from recommendations that it be offered seven days a week. 

Fewer than half of NHS patients who were in their last hours or days were told that they were dying by hospital staff, according to a critical report from the Royal College of Physicians (RCP), while a significant number of families and relatives are left feeling they have no emotional support.

The report also highlights the continued lack of specialist palliative care at weekends, 10 years on from Nice recommendations that it should be offered seven days a week.

Complaints by families that dying relatives were not given fluids were one of the chief spurs to an investigation and later withdrawal of the Liverpool Care Pathway – a protocol intended to help people to die well. The RCP audit, which included some who were on the Pathway and others who were not, found that 59% of patients were assessed to see whether they needed fluids through a drip – but conversations about thirst were held with only 17% of patients and 36% of relatives and friends.

The report, which investigated 6,580 deaths in 149 hospitals during May last year, concludes that wide-scale improvements are needed to ensure that care and support for the dying is consistently good.

Half of those dying spend their last days in a hospital, but the RCP’s inquiry suggests some hospitals are a far better place in which to die than others.

“The fundamental problem is about whether this is a national priority and whether this is an NHS priority,” said Dr Kevin Stewart, chair of the RCP’s audit steering group. “We don’t think this area has been given enough prominence.”

According to the findings, doctors and nurses had recognised that most of the patients (87%) were in the last days of their life, but talked about it with less than half (48%) of those who were considered capable of having the discussion. In 93% of cases, however, they told relatives, on average 31 hours before the death.

Most patients were prescribed medication when they needed it for the five key symptoms experienced at the end of life – pain, agitation, noisy breathing, difficulty breathing and nausea and vomiting. Not all needed the drugs, but in the final 24 hours 44% were given pain relief and 17% medication to help with shortness of breath.

Three-quarters of the 858 bereaved family members questioned felt they were involved in decisions about the care and treatment of their dying relative – but a quarter did not and 37% thought the emotional support given to them by the healthcare team was only fair or poor.

The report also found there was very little training for hospital staff in the care of the dying, in spite of national recommendations -– it was mandatory for doctors in only 19% of Trusts and for nurses in 28%. Almost half (47%) of Trusts did not have a named board member with responsibility for care of the dying.

“A core job of any hospital is to care for the dying, yet this audit shows this care is still not being prioritised,” said Dr David Brooks, president of the Association for Palliative Medicine (APM).

“Ten years on from Nice recommending that specialist medical and nursing services should be available seven days a week in palliative care, only a fifth of hospitals are in a position to provide this level of care.”

In the light of the Francis Inquiry and the “More Care Less Pathway” report by Lady Julia Neuberger into the Liverpool Care Pathway, “we find this very troubling”, said Brooks.

“Although we all face dying at some point, there isn’t adequate training and access to specialist support in the majority of hospitals to ensure all dying patients receive the care they deserve whenever they need it,” he added.

“It should be a basic entitlement for a dying person to have high quality, compassionate end of life care. This requires those caring for them to have adequate basic training and access to specialist support when needed, irrespective of where they are in the country.”

Dr Stewart said that although some aspects of care are good in hospitals in England, “I am deeply concerned that some hospitals are falling short of the excellent care that should be provided to both dying people and those important to them. In particular, communication with patients and their families is generally poor. It is disappointing that hospitals don’t seem to recognise this as an important issue, not just for those experiencing this in their own lives, but for the wider public.

“Everyone wants to know that if they are in the same situation, their needs and those of their families, friends and those important to them will be met, with clinically appropriate treatment, sensitivity and compassion.”

Professor John Ellershaw, director of the Marie Curie Palliative Care Institute in Liverpool, said: “It is unacceptable in the current day and age that hospitals are failing patients, and their families, in the care they receive at the end of their life. Too many patients are dying badly in our hospitals when we know how to care for them well.”

Richard Berman, a consultant in palliative care medicine at the Christie Hospital in Manchester, knows his patients are going to die. They have terminal cancer. But when they are in their last days of life, he will tell them only as much as they want.

“It’s not something that you have to let everybody know. The better way of putting it is that the patient should be given the opportunity to learn about what is happening to them,” he said.

He – or someone else on the palliative care team – will ask a broad question in as sesnsitive way as possible, such as “How do you think things are going?”. The patient might respond, “I’m not sure they are going very well”, which gives the doctor the chance to ask, “Would you like me to explain more about what’s going on?”.

It’s a step by step process, said Berman. “There’s never the bombshell question that they are not expecting,” he said. “Not every patient wants to hear more – in which case, the conversation stops there.

It’s difficult to have hard and fast rules about how you do this,” said Berman. “Everyone is different and has a different personality and different culture and background. There should be a very flexible approach.”

Even some people who do want open and frank discussions can get upset, “but the majority know anyway that things weren’t going so well and just want confirmation of that”.

“Sometimes patients are poorly or may become poorly quickly and you may miss the opportunity to have these discussions.” Conversations with family and friends and support for them are also critical. “This is a very sensitive, distressing and difficult time for them. They need to be kept involved in discussions and up to date with what is going on,” he said. At the Christie, they really get few complaints, but “emotions run high. If relatives are distressed and angry and upset, the way forward is to sit them down and explore why. Often it is something that is fairly easily resolvable. It is all about sensitive and open communictaion.”

BMJ rejects scare stories on statins following plea from Oxford professor

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Collins says claims 18-20% of those on statins suffered side effects did ‘disservice to British and international medicine’
Statins pills
Collins complained that the authors were creating unease in patients prescribed statins to protect them against heart attacks and stroke. 

The authors of two papers published by the British Medical Journal have publicly retracted statements they made about the frequency of side effects experienced by people taking statins, following a charge by an Oxford professor that the information was wrong and could endanger lives.

Prof Sir Rory Collins told the Guardian in March that a paper and a subsequent article in the BMJ were inaccurate and misleading. They had claimed that 18%-20% of people on the cholesterol-reducing drugs suffered adverse events. Collins called on the BMJ to withdraw them and complained that the authors were creating unease and uncertainty in British patients prescribed statins in large numbers to protect them against heart attacks and stroke.

“It is a serious disservice to British and international medicine,” Collins told the Guardian at the time, claiming that the alarm caused was probably killing more people than had been harmed as a result of the paper on the MMR vaccine by Andrew Wakefield. “I would think the papers on statins are far worse in terms of the harm they have done.”

The paper, by John Abramson and colleagues, questioned the decision to extend statins to thousands of people at low risk of heart attacks and strokes, saying that the drugs had not been proven to save lives in that group. They also claimed that an observational study had shown that 18%-20% suffer side effects from statins. An article by cardiologist Aseem Malhotra published the same week repeated the figure. Both authors have now withdrawn that statement.

In an editorial published in the BMJ, author Dr Fiona Godlee said the error was due to a misreading of the data from the study and was not picked up by the peer review process. “The BMJ and the authors of both these articles have now been made aware that this figure is incorrect, and corrections have been published withdrawing these statements,” she writes.

Benefits of statins outweigh risks, says medicines regulator

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MHRA says evidence from clinical trials shows statins can save lives by reducing risk of heart attacks and need for surgery
Statin pills
Statin pills. 

Millions of people prescribed cholesterol-reducing statins should continue to take them because the benefits outweigh the risks, Britain’s medicines regulator said on Friday. The Medicines and Healthcare products Regulatory Agency (MHRA)issued a safety update following a row over the frequency of side effects from the drugs. It said evidence from large clinical trials showed statins could save lives by reducing the risk of heart attacks, strokes and the need for heart surgery.

Its advice to health professionals said at least 450 deaths from heart attacks, stroke or vascular failure would be prevented for every 10,000 patients treated, if patients with a 20% risk or more of suffering such a cardiovascular event over a 10-year period took statins for at least five years.

The update came after the British Medical Journal(BMJ) commissioned an independent panel to report on how claims that 18-20% of people on statins suffered adverse events were published in the journal last year .

The verdict is expected by the end of July. The authors of two articles using the figure, John Abramson, from Harvard medical school, and Aseem Malhotra, a UK cardiologist, have withdrawn statements on the frequency of side effects following a charge from Prof Sir Rory Collins of Oxford University that the information was inaccurate and could endanger lives.

Collins, a leading advocate of statins, has argued that both articles should be withdrawn completely, saying they had caused uncertainty in patients. He suggested they could lead to far more harm than the scare over the MMR vaccine caused by the now discredited Andrew Wakefield.

Statins are currently being taken in Britain by about 7 million people who have at least a 20% risk of a heart attack or stroke in the next 10 years. The National Institute for Health and Care Excellence (Nice) recommended in February that statins should be given to people at only 10% risk – a move that could dramatically increase the number of people taking them.

Statins, the ethics of preventive medicine, and the nocebo reaction

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The Royal Colleges of Physicians and GPs are opposed to Nice proposals for population-level prescription of statins (Doctors call for rethink on prescribing statins, 11 June). As one of the designers of the Newcastle University simulation on healthy ageing, it is gratifying to see this scenario being played in the real world. Coming in the same week that we hear that one-third of the population is at high risk of type 2 diabetes, perhaps we can consider an even more interesting scenario: tagging obese patients with stepometers? If this is combined with rewards and penalties, the question is also ethical and philosophical, not medical: by what moral authority should doctors control behaviour? A scenario today, but reality tomorrow?

Prevention of avoidable diseases is starting to look like the only way to save the NHS from bankruptcy, but this requires the NHS to become a behavioural-change organisation that promotes certain lifestyles. The power is there to do this. The GP contract can pay doctors to fill this new role, but isn’t that morally dubious? Health follows an income gradient: the lower the income, the more unhealthy the “lifestyle”. Unhealthy lifestyles of people on lower incomes are not freely chosen. Low pay, unemployment, and low social and economic status funnel through to low self-esteem. Stress and depression increase the risk of self-treatment via tobacco, alcohol, sugar and fat. Lower income also increases your likelihood of living in poor housing, and not being able to afford healthy food or exercise properly.

Doctors can intervene by filling people up with statins or forcing patients to wear new technology to monitor activity, blood sugar and cholesterol. Delivered at the population level, these measures will work by skating over the biggest cause of poor health, which is low income. Are doctors prepared to do this dirty work? They have a choice. Physicians and GPs are firmly camped in the top 1% of income. As inequality is becoming a hot topic and we are heading towards an era when unequal incomes might be addressed, might the colleges set an example by voluntarily limiting doctors’ pay to a multiple of average income? Taking a hit in your own wallet is a powerful step, as befits the hallowed status of medicine.

1948. Doctor-patient consultation
Kenneth Charman
Visiting fellow, Changing Age Network, faculty of medical sciences, Newcastle University

• I was interested in Sarah Boseley’s mention of the “nocebo effect” (Professor at centre of statins row says public being misinformed, 14 June), although it didn’t quite explain the nature of this phenomenon, which really has little if anything to do with middle age, and perhaps more to do, as she says, with people just not wanting to be on pills. My late father, Dr Walter Kennedy, first coined the term “nocebo reaction” in a medical paper back in 1961. He used the Latin nocebo (“I shall injure”) as the opposite of placebo (“I shall please”) to indicate any unpleasant response to real or dummy treatment, this being a response within the patient themselves, and not due to the pharmacological action of a medication.

In other words, there is not a “nocebo effect”, only a “nocebo response”. Unfortunately, the term nocebo is sometimes used incorrectly for an active drug’s unwanted pharmacologically induced negative side-effects. Kennedy clearly stated that nocebo responses should never be confused with true pharmaceutical side-effects.
Dr Peter Kennedy
Wivenhoe, Essex

Professor who sparked statins row says government should intervene

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Prof Sir Rory Collins says he has little confidence in British Medical Journal’s inquiry into papers on side-effects of drugs
Prof Sir Rory Collins
Prof Sir Rory Collins said fears over statins could cause ‘very large numbers of unnecessary deaths from heart attacks and strokes’. 

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 to decide whether two papers it published last year that made an error on the extent of side-effects should be completely withdrawn.

The papers published by the BMJ 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 statements on the frequency of side-effects 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.

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.”

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.

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.

Should I take statins?

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Some doctors are sceptical about the benefits of taking statins, while others believe people are suffering heart attacks and strokes because of misleading information
Nice recommends statins to prevent cardiovascular disease in those with high and intermediate risk.
Nice recommends statins to prevent cardiovascular disease in those with high and intermediate risk. 

Scaremongering about statins by doctors could have caused 2,000 deaths, said a report last week. These would be the lives lost through people listening to the debate on the drugs and deciding to ditch them and risk a heart attack or stroke. The health watchdog Nice recommends statins to prevent cardiovascular disease in those with high risk (greater than or equal to 20% at 10 years) and intermediate (greater than or equal to 10% at 10 years) risk.

I should declare my conflict of interest. I work for the BMJ, purveyor of statin scepticism. The medical journal has raised the blood pressure of Professor Peter Weissberg, medical director of the British Heart Foundation, who said at a press conference this week that the BMJ was opposed to medicalisation of the “normal population”. The BMJ entered the statin debate in 2013, publishing an article that said (I paraphrase) that the benefits of statins were overstated, while their side-effects were undercooked.

The rate of side-effects such as muscle pains quoted in the article (18-20%) was hotly disputed by some cardiologists and epidemiologists. It was later revised to up to 9%. The “lives lost” figure is taken from another BMJ paper published this week, extrapolated from GP data showing 200,000 people may have stopped taking statins because of the media furore. However this, like the initial BMJ paper, is based on observational data – so doesn’t prove cause and effect. It also, most importantly, ignores that people of sound mind might actually decide to stop taking statins for other reasons.

The solution

The answer isn’t a quick yes or no, but a conversation to have with your doctor. If you had that conversation with Dr Malcolm Kendrick, a GP from Macclesfield who has researched and written about statins, it would go like this: “If I was taking a tablet every day for the rest of my life, I would want to know how long I would have extra to live. If you take statins for five years and you are at higher risk, then you reduce the risk of a heart attack by 36%. But if you rephrase the data, this means on average you will have an extra 4.1 days of life.” He warns that the risks are based on old data when heart attacks were more common – one study found that risk calculators overestimated the risk by four or five times.

Even the Nice decision support tool for patients says that if 100 people at intermediate risk (greater than or equal to 10%) took statins for 10 years, then four people would be saved from having a cardiac event or a stroke. This may be enough for you. But it should be your decision and not a given from anyone.

Don’t throw away your statins yet – LDL cholesterol is still probably bad for you

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A new study has claimed that there’s no link between LDL cholesterol and mortality in the elderly, but the majority of evidence disagrees

Statins are extremely commonly prescribed, and have been for many years, but until recently they have been recommended only in people at high risk of cardio-vascular problems, and that means people with high LDL cholesterol levels.
Statins are extremely commonly prescribed, but until recently they have been recommended only in people at high risk of cardiovascular problems, and that means people with high LDL cholesterol levels. 

“Throw away your statins, they’re not doing you any good,” reads a tweet I saw earlier. The reason, a study published in BMJ Open that has found no association between low-density-lipoprotein (LDL) cholesterol levels and mortality*, in individuals aged 60 or over.

The study in question is a systematic review of cohort studies that have looked at this and, in 19 studies on a total of 68,094 people, found no evidence that LDL cholesterol levels predicted mortality. But a closer look at their methodology reveals the study is weak in terms of being able to provide evidence of (a lack of) a causal link, and there’s currently much stronger evidence that does support of a link between LDL cholesterol and mortality.

Cohort studies versus randomised controlled trials

Firstly, the current systematic review assesses cohort studies. This study design takes a (hopefully) random group of people, assesses their cholesterol level at baseline, and then observes them over a period of time. There is no way to randomly decide who will have higher or lower LDL levels, and this is a big limitation. There will be differences between people with low LDL and high LDL cholesterol other than these levels, and these differences could be causal – they could affect LDL level, and risk of mortality. All of these differences must be taken into account in an analysis, or there’s a likelihood that an effect you’re seeing could be because of these things, rather than LDL itself. For example, if a person is already ill at baseline, they could have lost weight due to this, and therefore have lower LDL, but be at a higher risk of mortality. Some of the studies included in their review excluded people with terminal illness at baseline, but not all did.

This problem, known as “residual confounding” is a real issue for observational epidemiology, and sadly there have been a number of occasions when associations that have looked really consistent in cohort studies have been found to not exist when randomised controlled trials are conducted, or even worse have the opposite effect. In the case of LDL-cholesterol and mortality, RCTs of statins (which reduce LDL-cholesterol) have consistently shown a benefit on risk of major vascular events, even in people at low absolute risk of these events.

Also, although this paper is a “systematic review” of cohort studies on this topic, meaning the existing literature is methodically searched to attempt to minimise bias, this review wasn’t able to search more than one database for papers, and hasn’t included work published in languages other than English, or unpublished work, meaning that bias hasn’t necessarily been minimised.

Confounding by treatment with statins between baseline and outcome

Statins are extremely commonly prescribed, and have been for many years, but until recently they have been recommended only in people at high risk of cardio-vascular problems, and that means people with high LDL cholesterol levels. They are also very effective at lowering the levels, so if the cohort studies included in this systematic review were confounded by statin prescriptions after baseline, this could explain why those with initial high levels of LDL ended up at lower risk. In an ideal world, you’d only recruit people who weren’t going to be given statins at all (or do an RCT, as discussed above).

The authors of the review note in their paper that it’s possible that people with high LDL levels at baseline might be more likely to be prescribed statins while the study they are in is ongoing. This is likely to be a really big confounder in their study, which could be the reason it looks like high levels of LDL are protective. Without being able to know whether this is the case, it’s really hard to interpret these findings.

Response from the academic community

Scientific studies undergo peer review in the hope that this will lead to higher quality research, and catch mistakes before they are published and enter in to the scientific literature. The BMJ Open even goes so far as to publish the peer reviewalongside the paper. From this, it can be seen that misgivings were felt by the reviewers about this paper. Not only that, but the Centre for Evidence Based Medicine has written a detailed blogpost they’ve described as ‘post-publication peer review’ detailing the methodological weakness of the paper. The British Heart Foundation have also issued a statement, which concludes by noting “there is nothing in the current paper to support the authors’ suggestions that the studies they reviewed cast doubt on the idea that LDL cholesterol is a major cause of heart disease or that guidelines on LDL reduction in the elderly need re-evaluating.”

All research papers have limitations, and the authors of this study list some limitations on the first page of the article. But it is worrying when one paper is used publicly to attempt to overturn the current weight of scientific advice around diet, health, and statins, when the strength of evidence doesn’t warrant this. The strongest current evidence, from randomised controlled trials, supports the use of statins to reduce cholesterol, and crucially, to improve health. And a healthy lifestyle and diet won’t do you any harm either!

*And yes, to the pedants, of course everyone’s risk of mortality is 100% eventually, but risk of mortality in this instance refers to risk within the duration of the study.

Mediterranean diet better than statins for tackling heart disease

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Study finds people already suffering from heart problems are 37% less likely to die early if they eat a diet rich in vegetables, nuts and fish

The study followed 1,200 people with a history of heart attacks, strokes and blocked arteries over seven years.
The study followed 1,200 people with a history of heart attacks, strokes and blocked arteries over seven years. 

Heart disease is better treated with a Mediterranean-style diet than cholesterol-lowering drugs, it has been claimed.

A study found those who had a diet rich in vegetables, nuts, fish and oils were a third less likely to die early, compared with those who ate larger quantities of red meat, such as beef, and butter.

Speaking at a global conference on heart disease in Rome, leading heart disease expert Prof Giovanni de Gaetano said: “So far research has focused on the general population, which is mainly composed of healthy people.

“What happens to people who have already suffered from cardiovascular disease? Is the Mediterranean diet optimal for them too?”

The study followed 1,200 people with a history of heart attacks, strokes and blocked arteries over seven years. During that time, 208 patients died but the closer people were to an ideal Mediterranean diet the less likely they were to be among the fatalities.

The conference was told those who ate mainly along Mediterranean lines were 37% less likely to die during the study than those who were furthest from this dietary pattern, after adjusting for age, sex, class, exercise and other habits.

Previously, cholesterol-lowering drugs such as statins were believed to be the most effective method of combating heart disease, the leading cause of death in the UK.

Statins, which are among the world’s besselling prescription drugs, are said to help reduce major heart problems by around 24%. They are the most widely prescribed drugs in the UK, with at least 7 million users costing the NHS £285m a year.

According to the latest figures from the British Heart Foundation, cardiovascular disease causes more than a quarter (27%) of all deaths in the UK – around 155,000 deaths each year – an average of 425 people each day or one death every three minutes.

Sir David Nicholson, former chief executive of the NHS, entered the debate over statins in July when he said he had stopped taking them as part of his medication for diabetes. “If a lifestyle change works then why would you take the statin? The trouble is that they give you a statin straightaway, so you don’t know what is working,” he said.

Statins prevent 80,000 heart attacks and strokes a year in UK, study finds

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Study in Lancet says risk of side-effects has been exaggerated and controversy will cause 2,000 extra heart attacks and strokes over next decade

Several different types of statin pills
Authors say the benefits of taking statins have been under-estimated while the harms have been exaggerated. 
 Statins to lower cholesterol prevent 80,000 heart attacks and strokes every year in the UK, far outweighing the harm from rare side-effects, according to a review of the evidence which aims to put a heated controversy to rest and reassure the public that statins are safe.

The review is published by the Lancet medical journal, whose editor, Richard Horton, likened the harm done to public confidence by the critics of statins to that caused by the paper his journal published on the MMR (measles, mumps and rubella) vaccine in 1998.

“Controversy over the safety and efficacy of statins has harmed the health of potentially thousands of people in the UK,” he wrote in a comment published with the review. In six months after the publication of “disputed research and tendentious opinion” on the side-effects of statins in 2013, a study estimated that over 200,000 patients stopped taking a statin. It predicted there would be 2,000 extra heart attacks and strokes over the next decade as a result.

The Lancet was taking a stand, he said, “because of our experience of MMR. We saw in a very painful way the consequences of publishing a paper which had a huge impact on confidence in a safe and effective vaccine.

“We learned lessons from that episode and those lessons need to be widely promulgated. They are lessons for all journals and all scientists.”

The furore over statins broke out after Nice, the UK’s National Institute for Healthand Clinical Excellence, advised doctors in 2013 to prescribe statins for patients with a low, 10% risk of heart disease in the next 10 years, which was half the previous level of a 20% risk. It made 4.5 million more people, who were fundamentally healthy, eligible for statins, which Nice said could prevent up to 28,000 heart attacks and 16,000 strokes each year.

The guidance, which was based on evidence from the group led by Prof Rory Collins at the clinical trials service unit at Oxford University, was questioned by the British Medical Journal, which is campaigning against the over-use of medicines and medical treatment. The BMJ ran two papers claiming statins did not reduce deaths and that the risk of side-effects outweighed the benefits.

Collins severely criticised the papers and the BMJ, arguing in the Guardian that they could harm more people than Wakefield did with his MMR paper. Wakefield suggested a link between the jab and autism, deterring some parents from having their children vaccinated.

In the light of the loss of confidence in the pills, the new review of the evidence on the benefits and side-effects, led by Collins, was intended to help doctors, patients and the public make an informed decision about statin therapy, it said.

About a third of those who have already had a heart attack or stroke and would be eligible for statins are not taking them, and that rises to a half among those in the low-risk group. Many do not want to take pills because they do not consider themselves ill, while others worry about side-effects.

The authors say the benefits of taking statins have been under-estimated while the harms have been exaggerated. Treating 10,000 high-risk patients prevents 1,000 heart attacks or strokes and treating 10,000 low-risk patients prevents 500, they say. In the UK, about 2 million people at high risk – because they have suffered a heart attack or stroke – and about 4 million at low risk take statins.

About 40,000 people in each group – a total of 80,000 – avoid potentially fatal heart attacks and strokes as a result, said Collins.

He and his fellow authors stressed that their findings were from randomised controlled trials, which have compared large groups of similar people, some on statins while others were not.

The statins critics generally cite findings from observational studies, Collins said – that is data from people who have been taking statins in the real world, but without a carefully selected comparison group who have not been on the pills. That makes it hard to tell whether any problems are actually caused by the drugs.

There are side-effects, says the review. There is a real risk of myopathy, a neuromuscular disorder which causes muscle damage. One in 10,000 people per year will develop myopathy as a result of this. Another five to 10 people will have a haemorrhagic stroke, which involves bleeding into the brain and 10 to 20 people on statins are diagnosed with diabetes.

There have been claims that as many as 20% of patients have “statin intolerance”, with claims of muscle weakness and pain. At most 10 to 20 in every 10,000 have an increase in such symptoms on the drugs, says the review.

Some GPs have been among the sceptics over statins, but Dr Maureen Baker, chair of the Royal College of GPs, said the study cut through the controversy. “It recognises the benefits that these drugs have for many patients, but also the potential side-effects that any prescribing healthcare professional should be aware of.”

GPs would never take a decision to prescribe statins lightly and should only do it after a discussion with the patient and the medication should be regularly reviewed, she said.

“We hope this research reassures patients who are on statins that in the majority of cases statins are safe and effective drugs – but in most cases where adverse side-effects are seen, these are reversible by stopping taking statins.”

Consultants spoke of struggling to persuade patients that the drugs would help them. “I often meet people who don’t want to take statins yet are happy to take other drugs with greater risks of side-effects, or take supplements with no benefit at all,” said Dr Tim Chico, a consultant cardiologist in Sheffield. “Statins have been unfairly demonised, and this prevents a sensible discussion of the risks and benefits of their use. Statins can cause side-effects, but the chance of developing these is low, while the effects of suffering the heart attack that a statin might have prevented can be fatal or life-long.”

Prof David Webb, president of the British Pharmacological Society, said: “In recent years, those of us who manage the large number of patients at excess risk of heart disease and strokes have been fighting an uphill battle to persuade them to take statins, a class of medicines that have been repeatedly shown to save lives.

“The problem has largely related to concerns about muscle aches and potentially more serious side-effects (muscle damage, diabetes and haemorrhagic stroke) that have been very well publicised on the internet.

“Many patients who have much to benefit from statins, and many of those at more modest risk, have been persuaded not to take them because of exaggerated claims of harm, and some research suggesting that the benefits have been overestimated. It is likely that many lives have been lost, based on a received view that statins are dangerous and ineffective.”