In the Scottish Parliament, Labour leader Johann Lamont has raised the case of a cancer patient who is “considering moving to England to get free access to drugs she cannot be prescribed on the NHS in Scotland.” Lamont is critical of money being used to pay for paracetamol while this drug is not prescribed.
Cetuximab is a drug prescribed in certain cases of advanced cancer, principally colo-rectal or head and neck cancer; in both circumstances it’s used for a relatively short period in combination with other therapies. It’s approved for use in Scotland and England and Wales on similar terms, but the terms are highly specific. Three issues are worth noting. One is that while the treatment does lead to an improvement in life expectancy, the improvement is very small – two to four months, assuming best supportive care. The second is that the drug is dangerous: “Cetuximab has a non-trivial safety profile and data are compatible with an increased risk of death in patients administered cetuximab as add-on to chemotherapy.” (Scottish Medicines Consortium) The third issue, as often happens, is that the drug is also very costly – the Health Technology Assessment suggests that the manufacturers have underestimated both the duration of treatment and the cost of supportive care.
It’s not possible to tell what the basis is for the decision about the particular patient identified in the Scotsman, and I’m not going to try. It’s not difficult to understand, however, that decisions about prescription have to be made in a specific context, for a specific person, and that different decision-making bodies may reasonably arrive at different conclusions.
Paracetamol, by contrast, is a largely beneficial drug, prescribed in well over two million cases in Scotland every year. The idea that Scotland should stop prescribing it in order to facilitate paying for expensive drugs with very limited benefits doesn’t look like sound policy.
Although the situations considered in the Francis report are shocking, the situation they describe is all too familiar. The scandalous ill-treatment of patients was a recurring problem of long-stay institutions – reflected for example in Sans Everything (1967) and a string of scandals in mental institutions, detailed at length in J Martin, Hospitals in Trouble (1984), a book cited in this inquiry report. Nearly thirty five years ago, as a student, I was given an advance copy of the Normansfield report by Brian Abel-Smith; it described how patients were restricted and neglected, and the upper echelons of NHS management did nothing about it. David Ennals explained, in Parliament: “… the report makes clear that there were many people who knew just what the position was. Some of them were in positions of authority with power to act but they failed.” In other words, we have been here before. The main difference is that this time it’s in acute care.
Unfortunately, the Francis report does not point to the way out of the problems. There are some hard-hitting passages – given the findings, there had to be – but there’s an awful lot of words in between. At nearly 1800 pages, the report is rather badly written – indiscriminate, repetitive, with some slushy, mystical twaddle about leadership (the stuff about it being a quality of the ‘spirit’ is in there twice) and an 125-page “Executive Summary” (someone should have taken the learned chairman into a corner and explained what that phrase is supposed to mean). The review of evidence in volume 1 is generally good; Volume 2 spends several hundred pages reviewing what regulatory and supervisory agencies did not do, and is interminable; the review of general issues in volume 3 is long, prescriptive and often preachy. The sheer number of words guarantees however that it won’t be read.
The stuff on leadership presents the most obvious problem. This report uses the word more than 800 times, referring to leadership haphazardly whenever it wants to think about the position of people in charge, senior management, ward management, roles in professional settings, personal qualities, motivation, or relationships with juniors. The poisonous cult of leadership, and the assumption that people in charge should energetically push others to share their values and aims, is part of what’s created this mess in the first place. What the report is really describing is systemic failure, and systemic failure cannot be responded to through on an individualistic basis without gaps being left.
Reform Scotland has published a pamphlet arguing that since GP practices are insufficiently sensitive to patients’ needs, the answer must be to promote competition between providers. That doesn’t follow. When markets are based on ‘choice’, the choices that are made are not just the choices of consumers; they are also the choices of providers. Competition works because providers refine and select what they do. They choose who their customers are. They choose their location. Making the right choices cut costs; that is why competitive markets tend to be efficient (and why public services aims for ‘cost-effectiveness’ instead of efficiency – the aims are very different). The selective decisions of providers, within the current system, are precisely the reasons why patients do not get what they need. Which practices are going to cover people in isolated rural locations? Who is going to provide services to drug users, who use GP services at ten times the rate of other people? Who is going to provide services to very elderly people, who cost practices seven times the resource of other patients? Competition is not the way to a universal service; it is the opposite of what is called for.
The press reports, again, that patients are being denied life-enhancing drugs to save money. In this case, the issue centres partly from the draft guidance prepared by NICE on Abiraterone, and partly on the impression in Scotland that the drug in question may be partly responsible for the unexpectedly long survival of a convicted murderer.
NICE gets a terrible press, but the work they do is exemplary. The consideration given by the committee is, as ever, consistently careful, thorough and balanced. Their brief was to review
- Overall survival
- Progression-free survival
- Response rate
- Prostate specific antigen (PSA) response
- Adverse effects of treatment, and
- Health-related quality of life.
There is a case for Abiteraterone. It does extend survival by about four months – roughly a third more than without the drug – and it seems to have fewer side effects than the existing drugs. However, the benefits are still limited, and the drug is hugely expensive.
This specific example seems to fall into a category discussed in a debate in the British Medical Journal in 2009 (31st January). Adrian Towse, the director of the Office of Health Economics, argued that the public were generally willing to support payments that were double what NICE was allowing for. The NICE thresholds were typically a cost of £20-30,000 for each QALY (a year of valued life), a figure that has been raised for end of life treatments; the public would support £30-70,000. Against that, James Raftery argued that the thresholds should be lower, because they force health trusts to take resources away from other, more effective treatments. The cost of Abiraterone falls in the region of £53,800 to £63,200 for each QALY.
There is beyond that a common problem: the evidence in this case is almost entirely supplied by the drug’s manufacturer. Manufacturers have only a limited window during which they can market a drug before patents expire; spending time to run all the tests, and in particular to identify the groups best able to benefit, is not always consistent with their financial interests. It is not clear whether Abiraterone does extend survival more than all the alternatives, because the manufacturer has not yet made all the necessary comparisons. If the gaps could be closed, the case for approving the drug would be stronger.
On 8th February I suggested that some groups might reasonably be exempted from the process of reassessment for ESA, and mentioned in particular “young people with severe disabilities from early ages or people with defined conditions like cancer”. The recent statistical release tells us that these groups have a quite different profile from most other claimants. As things currently stand 12% of all claimants are being placed in the “support group”, those who are not expected to work. In the case of “neoplasms”, or cancer, that rises to 67.7% of assessed claims; in the case of “congenital” or “chromosomal” conditions, it is 66.7%.
The reports of delays in access to Employment and Support Allowance are unsurprising. The finger of blame has been pointed at Atos Healthcare. Atos has been the subject of a barrage of criticism during the last couple of years; their processes were described by the Harrington report as “mechanistic” and “impersonal”; many of the decisions made about fitness to work are wrong and 40% of appeals have been successful. Atos has issued a statement attributing the delays to the longer, more sensitive assessments introduced since Harrington.
There is however a more general issue about the capacity of the administration to deal with mass reassessment. Governments have not just undertaken in recent years to reassess all the former claimants of incapacity benefit; they also propose to introduce equivalent tests for the Personal Independence Payment, the reformed Disability Living Allowance. As people with disabilities are displaced from the labour market, and as the government requires further categories to be ready for work, including lone parents and those who are bereaved, the demands on the system of reassessment will increase. Current calculations on throughput rely heavily on people not turning up for the assessment.
There are some practical ways of relieving the burden of administration. One is to exempt more groups – such young people with severe disabilities from early ages or people with defined conditions like cancer. Another might be to offer compensation to some people to transfer to JSA voluntarily. A third might be to license a range of independent practitioners to certify the assessment. The procedure needs to be faster as well as fairer.
The stigmatisation of claimants with disabilities is not a new phenomenon – people with disabilities have always prompted a combination of apprehension, mistrust and vilification. Precisely because it is deep-rooted in society, it can be dangerous. Governments which are critical of vulnerable groups are liable to legitimise the process of social rejection and exclusion; in the worst cases, they can exacerbate the process. That is behind the concern expressed by certain charities in a recent Guardian report.
Social security benefits for people with disabilities are not provided for a single purpose. They are provided for many reasons – among them, need, low income, social protection, compensation, earnings replacement, social inclusion and rehabilitation. Part of the problem with “othering” disability – and indeed, part of the problem with treating disability as an issue in identity politics – is that so many different issues are folded up together. Anyone can become disabled; it can happen suddenly as well as gradually. A benefits system needs to protect people from the things that might happen to them, and a system which excludes disability fails in several of its primary purposes.
A report by Carol Black and David Frost makes proposals that are supposed radically to reduce the flow of people moving on to Employment and Support Allowance. The argument that this can be done is built on the belief that the initial response to illness makes it more likely that people will adjust to long term sickness by claiming benefits. However, the most substantial reduction that is foreseen in the report is in the numbers of people who move directly to long-term benefits without going to employment in between. This group includes people who would formerly have claimed Severe Disablement Allowance.
Despite the reports about “sick note” Britain, benefits are not in general issued with sick notes – or “fitness for work notes” as we must now learn to call them. GPs didn’t, in general, get to sign people onto Incapacity Benefit, and they don’t sign people onto Employment and Support Allowance. However, there are some exceptions. If a person is not entitled to Statutory Sick Pay, typically because their employment has been terminated, they will be put onto ESA directly. If they have certain illnesses, principally terminal illness and life-theatening conditions, there may be no requirement to undergo a Work Capability Assessment. Those exceptions will be maintained. The main proposal in the report is that such claimants should move directly to the WCA. It is not immediately clear how this procedure is going to deliver a substantial cut in the number of successful claims.
The NHS in Scotland has been blighted by creeping centralisation. Hospital services have been progressively been sucked into the large, university-based hospitals in the major cities. The result has been growing problems with accessibility and equity, and a sense of alienation from the population that these hospitals serve. People do not simply want the best medical care possible – especially not if if means they have to travel away from their communities and their families in order to receive it. There are now many parts of Scotland where there is no cover on evenings and weekends, and over an hour’s travelling is needed to get help. Health care is all about social protection, and the first, basic rule is to make sure that people are covered when they need it. The resistance to the closure of Accident and Emergency (A&E) facilities in Monklands and Ayr is symptomatic of this. The understandable fear that people have is that the services will not be there when they need them, and they will have to travel long distances to get essential cover. One of the first actions of the new SNP executive has been to refer the issue back to the health boards for reconsideration.
The reform of A&E is not, however, just another example of centralisation. On the contrary, the development of A&E is itself an example of over-centralisation – formed in the belief that a unit can only function adequately if it has a critical mass, and all the bells and whistles that might be needed. The current arrangements don’t work – it’s not very long since A&E in Lanarkshire was virtually overwhelmed by the number of people reporting with a respiratory virus.
The Kerr report (9) argues that the problems of A&E can be dealt with by more decentralised, local services. The report makes a crucial distinction between Casualty and Emergency services. Kerr proposes a network of casualty units, each with the capacity to deal with lesser injuries and to stabilise life-threatening conditions. Kerr suggested that “as a rule of thumb, each current hospital offering A&E services should be able to sustain services for urgent care.” Emergency services, by contrast, will be more specialised, typically serving about a quarter of those who currently come into A&E.
The NHS boards in Lanarkshire and Ayrshire and Arran proposed, in line with the Kerr report, to replace A&E with a split between Casualty and Emergency units. In Lanarkshire, the plan would have increased the number of units dealing with casualities from three to five, with new units in Cumbernauld and Lanark. These 5 units were to cover 70%-80% of the load currently done in three places. Each, then, wouldl have only half the load of current A&E provision. Two further Emergency units, at Hairmyres and Wishaw, were to act as specialised backup. A&E in Monklands was to be downgraded – not closed – as part of a process which would have redistributed staff and facilities across seven units in five locations. The same pattern was proposed by NHS Ayrshire and Arran. Instead of two A&E departments there were to be five causalty departments and one emergency unit. A&E in Ayr would therefore be downgraded.
The purpose of these plans was to make services more local, less centralised, more accessible and much less overburdened. That is what people are now opposing. An attempt to decentralise is at risk of unravelling because of a demand to keep things as they are.
Note 9. NHS Scotland, 2005, Building a health service fit for the future.
The announcement that Herceptin (the brand name of trastuzumab) has been approved for early stage breast cancer has also been accompanied by fears that it will cost the NHS about £100 million, on the assumption that it will be routinely prescribed in cases where women have early stage breast cancer. On a recent court case, a women took her health authority to court for refusing to prescribe the drug prior to its approval by NICE, the National Institute for Clinical Excellence. She was convinced that not receiving the drug was tantamount to a death sentence, and she made several emotive appeals to the press. The Secretary of State for Health intervene to direct that she should receive the drug.
This has been seen as an argument about rationing, finance and costs. I’m not convinced that it is about rationing at all. The first issue it raises concerns the process of approval. In some countries, doctors are able to prescribe drugs fairly freely. In France, prescriptions or licensed drugs are permitted unless the drug has been entered on a list of “références medicales opposables”. In the UK, the opposite is true; doctors are unable to prescribe drugs on the NHS until they have been approved for use. The rationale for limiting prescriptions reflects fears that the information available to doctors is partial, and unduly influenced by the pharmaceutical companies.
In the case of Herceptin, there have been some disturbingly misleading reports – including one in the New England Journal of Medicine, which really ought to know better. The article examining the use of the drug (3) suggested that using it in the early stages had reduced the recurrence of breast cancer by “approximately 50%”, and the journal editorial took that on trust. The numbers in the article are not clearly stated, and they seem to be different in different tables, but nearly 1700 women received trastuzumab for a year, and a roughly equal number did not. 127 women receiving the drug had a recurrence of their cancer, and 220 in the other group had recurring cancer – an improvement, on the face of the matter, for 42% of the treatment group, not “approximately 50%”. Crudely put, 93 people, or less than one person in 18, seemed to benefit. What also needs to be mentioned is that 84 patients receiving the medication were taken off it or withdrew because of ill effects, and that 29 people suffered symptomatic congestive heart failure. What we seem to have, then, is a drug which is potentially beneficial for a few people, potentially harmful for a few others, and makes little difference to most. This kind of profile is not particularly exceptional.
The key problem for the NHS rests in the finding that some people are significantly worse off as a result of receiving the drug. When the NHS approves a drug, it doesn’t just go to one person; it goes to hundreds, and sometimes thousands. What risk is acceptable to improve the circumstances of some people, at the cost of danger to others? This is not a simple question of mathematics, and there is no numerical answer. The moral responsibility of the NHS is to do as much as it can to ensure that the benefits go to the people who need it, and that the dangers for others are minimized. There are more people who benefit that who suffer, which is encouraging, but not good enough. The normal procedure would be to use the results of successive tests gradually to refine the definition of the potential recipient group, so that it is used most appropriately for people who stand to benefit, and avoided for those who are most at risk. That is what the procedures for testing and trial are supposed to do; and that is what the political intervention has stopped. The first duty of any medical service lies in he principle primum non nocere, “first do no harm”. This, not the money, is what is at risk.
The problem of obesity is seen largely as a problem of nutrition and exercise. (There may be other contributory causes, such as sleep deprivation or the controlled temperature in heating systems, but this is still a reasonable generalisation.) Whenever exercise is mentioned, however, it is likely to be transmuted into “sport” in general, and competitive sports in particular. In several cases, absurdly, this has even been cited in support of Britain’s Olympic aspirations, as if sitting watching the Olympics with a pack of lager cans was going to inspire our transformation into leaner, fitter citizens. The sports lobby has kidnapped the idea of exercise, which is being held prisoner in a suburban room somewhere while an impostor takes its place. “Sport” is not the same thing as “exercise”, and even if sports are a way of exercising, they are not usually the best way.
An active lifestyle should mean that people are active across a wide range of ages, personal and social circumstances. Most people who have active lives do so through a variety of physical activities. The Scottish Health Survey classifies exercise for children in four categories – sport and exercise, walking, active play, and gardening and housework. Exercise for adults is mainly classified as home activity (including gardening, housework and DIY), work activity, and sport and exercise. (2) In relation to all categories, “sports and exercise” is at best a contributory factor – not the main one.
Within the category of “sport and exercise”, the role of “sport” itself is limited. Exercise includes walking and non-sporting activity such as dancing. “Sport” is fairly generally defined, including e.,g. swimming and jogging. Competitive sport and games are a residual part of exercise within the category of “sport”, and a tiny part of exercise overall. Engagement in sport is highest among young males; it is much less important for females, and it declines rapidly in importance with age, Team games are largely beside the point. If we want a fit, active lifestyle, encouraging walking and gardening are much more relevant than getting people to play football or rugby. Whether or not schools need a football pitch, they do need a garden more.
If it were just a question of not recognising what most exercise is like, there would be a case for doing sport as well as exercise. But that’s not the only issue. The culture of sport in schools, and particularly of team games, is profoundly alienating. Most schools in Scotland suffer from the dominance of football in the playground, where a few more competent boys participate, and the rest of the children are relegated to the corners of the open space. The obsession with competitive games leads to people avoiding physical activity. Sport, then, is part of the problem rather than part of the solution.
Note 2. Scottish Health Survey 1998, http://www.show.scot.nhs.uk/Scottishhealthsurvey/sh8-00.html.
This is drawn from arguments posted on the Radical Statistics mailing list.
Genes are not a blueprint for the way we live. Biologists distinguish between genotype – the underlying pattern – and phenotype, the observable outcomes stemming from the interaction of genes, environment and the combined process of development. The argument has been made that environmental factors can make genes more important. For example, myopia, a condition rooted in genetic makeup, has been exacerbated by the development of reading. Variation in height, which is clearly governed by genotype, is nevertheless largely produced by environmental factors (which is why height has increased in succeeding modern generations). To illustrate the point, we know that two centuries ago, even if they were drawn from the same genetic pool, people were much smaller and lighter than we are now. One French study records that 79% of male recruits in 1792-9 were below 1.5 metres tall. The difference between that range and the range of heights in contemporary society is large enough to move people with a similar genetic endowment from a relatively low position to a relatively high one, depending on the developmental environment (primarily, in the case of height, on nutrition). A similar comment can be made about obesity. Estimates for the hereditability of obesity vary between 40% and 70%; but anyone who imagines that recent increases in obesity are due to changes in genetics isn’t living in the real world.
Despite nearly 150 years of trying, no-one has produced any good evidence that genes affect developed social behaviour in humans. With about 42,000 genes, it is easy to find statistical associations – at the conventional level where p<.05, there will probably be 2100 genes associated with any given character trait – but that does not demonstrate any causal link. Beyond that, however, most studies making claims about genetic origins of behaviour do not even try to show that there is a general association between the gene and the behaviour. They have simply relied on the occurrence of behaviour in specific families (7), and families have shared environments as well as shared genes. To the best of my knowledge, no study has ever shown that any social competence, personality trait or pattern of behaviour, of any kind, is shared by people with a common genotype or combination of genes while it is not present in others without that genotype. This is the minimum data that would be required to show that genes determine such issues.
Many studies rely, instead, on twin studies, in the belief that the similarity between identical twins must be genetic. This has three obvious problems. Firstly, any similarities within families may well reflect similar environmental factors. Second, identical twins generally have social environments which are very similar, and certainly more similar than fraternal twins. That’s why past studies tried to concentrate on identical twins reared apart – the problem being that (a) not enough twins are reared apart to make for a valid study, and (b) that even when twins are reared apart, social services agencies try to match their environments to the greatest possible extent. Third, identical twins are only relevant if one begins from the proposition that their genetic endowment is crucial. In other words, the studies assume the phenomenon they set out to prove.
The argument is not just bad science, It was used at the end of the 19th Century to justify the isolation of “degenerates” from the rest of the community. It was the basis for eugenics. It was closely associated with fascism, because it is an argument that was made by fascists for political reasons and offered in justification of the extermination of inferior humans. (8) The argument is sinister, and it deserves to be treated with deep scepticism.
Update, 24th November 2012. New Scientist reports this week about Mendelian randomisation, and that serves as a reminder to me that this criticism is beginning to be dated. The genetic linkage studies that were just being developed when I wrote this (e.g. Lancet, 2005 Sep 17-23;366(9490):1036-44) have started to bear fruit. A new epidemiology, described in Palmer et al’s Introduction to genetic epidemiology, has moved away from the old fallacy that behaviour is simply determined by genes; it begins, instead, with the proposition that different environments affect people with different genetic endowments differently. That makes it possible to distinguish the circumstances of people with certain genetic patterns from others – which is just what I was complaining here that studies hadn’t done to date.