Rationing Herceptin

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 (1) 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.

Note 1. M Piccart-Gebhart et al, Trastuzumab after adjuvant chemotherapy in HER2- Positive Breast Cancer, new England Journal of Medicine 2005 353:1659-1672

The Farepak scandal

First things first. If I ask a cobbler to repair my shoes, and he goes bankrupt while my shoes are in the shop, the bailiffs have no right to take my shoes away. They are still my shoes, and I can l get them back. If I give money to a lawyer to pay for a house, it does not become the lawyer’s money; it will sit in a separate account. If I give money to a bank to safeguard, the bank does not become the owner of my money. I am their customer for the service I am receiving, and may be liable for charges or a charge against the interest, but it is still my money.

The Farepak scandal happened when a saving club went bankrupt. About £40m in savings were lost. Farepak’s bank, HBOS (Halifax Bank of Scotland), was able to recover about £35m of debts owed to it by Farepak. The “customers” have lost everything.

Something is seriously wrong here. The people who saved money with Farepak might be regarded either as depositors, or as customers. If they are depositors, the money recovered by HBOS still belongs to them. Irrespective of how Farepak ordered its accounts, the bank has actually recovered its losses from their money, and the bank is liable to restore it. If, by contrast, they are customers, and their “saving” was in fact payment by instalment for a service to be rendered, the situation is legally different – they become creditors, like others including the bank. The bank has acted legitimately, even if it might be thought to have taken advantage of the situation to recover assets before others could act.

This situation is still questionable, however. One has to ask whether the position of the unfortunate customer is morally equivalent to that of a lender or an investor, both of whom offer capital on the basis that there will be a return on their risk. Lenders and investors knowingly take a chance, and gauge the rate of return in that light. The customer, by contrast, is not engaged in risk-taking. That seems to me to imply, in the settlement of debts, an order of priority. The restoration of bailed goods and money should have priority over the repayment of loans. The “customers” should receive the £35m recovered by the bank. If the law does not say so, the law should be changed.

Additional note, July 2013. In 2013, the decision was taken to pay Farepak’s customers 50p in the pound. This followed a legal case where Mr Justice Smith commented: “This is not a court of morality but I would suggest that HBOS really ought to seriously consider whether or not they ought to make a further substantial payment to the compensation fund.”

The American ideology

Somehow or other, people in the US seem to have convinced themselves that they are individualists. Everyone is out for themselves, people have no responsibility to each other, and everything that is social is immoral. Like many myths, this view of the world has the capacity to become self-fulfilling. The quality of public life in the US – the physical structure of towns, the condition of public roads, the absence of transport – is appalling. The world looked on with horror when, after Hurricane Katrina, the world’s richest nation abandoned its poor, its disadvantaged and dispossessed and blamed them for not making their own arrangements.

There is, though, another USA. There is a USA where people live in families and neighborhoods, where people go to school with other people, where they worship collectively and give to charity. The word for this kind of behaviour, in Europe, is “solidarity”. People are in relationships of solidarity when they accept responsibility for each other. There are many Americans who are not part of patterns of solidarity – who are excluded. But most are not. The US seem torn between an image of its itself as a frontier populated by isolated individuals, and the reality that people experience day to day.

Most of the people I have talked to from the US seem to fall immediately into talking about state action. People are either “liberal”, by which critics seem to mean “interventionist” (the term in the UK means the opposite), or “conservative”. These positions are mainly defined in terms of how much state intervention there should be. The test for America is not how to build a welfare state, or even how to develop social welfare by other means. It is how to use the solidarities which exist effectively, for the benefit of its citizens.

The European social model has grown as a way of developing the links between disparate communities and traditions, and it might just be extendable to another rich, highly complex, culturally diverse, nation. The model is based on three core elements. The first is the development of solidarity – developing the things that tie people together, like family, community and culture. The second is the extension of solidarity, making sure that people have the opportunity to be part of solidaristic networks. And the third is the process of social inclusion, making sure that people who are excluded are brought into the net through a combination of obligation and rights. The idea of an “inclusive America” – a phrase once used by Pope John Paul II – has been raised by some religious and racial groups; but if anyone, either Democrat or Republican, was talking about this in the recent elections, I missed it.

Obesity and sport

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.  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.

 

Climate change

The Stern review on the economics of climate change presents an argument for preventative action, intended to stop the world from getting warmer. I don’t have the scientific background to judge whether or not the arguments about global warming are justified, or whether the predictions in the report are accurate. But I can tell that the proposals in the Stern report don’t follow from the analysis of the problems.

Assuming that Stern is right about the problems, the first question to ask is whether mitigation will work. The analysis in the report depends on the idea that there is a critical range of carbon emissions. If carbon emissions continue at more than that level, the situation will continue to worsen. If they reach that range, they might stop. I say “might”, because that is as far as Stern is ready to go. The estimates he cites suggest a probability of up to one in five that even if the reduction falls well below that range, the global temperature will still increase by 3 degrees – enough, according to the report, to displace 150 million people, and to put up to 500 million people at risk of starvation. What we are being offered, then, is a preventative approach that may not have any effect at all.

The second problem is that even if prevention is possible, it requires the cooperation of every nation. Stern is clear that any measure that fails to engage most of the world’s economies will fail to mitigate global warming. To justify any major investment on the part of a single country, we need to know that that nation’s contribution would make a difference proportionate to its expenditure, or at least some difference. There is no indication that it would.

The third problem is that the solution that Stern proposes – a global market for carbon emissions – could make things worse. Countries in the process of development will be fettered; they can develop under constraints, or they can sell their rights, which offers a short-term return but traps them in dependency. The main way out of the dilemma will be to develop nuclear power – a paradigmatic case of the West willing the end while denying developing countries the means. Stern’s world will be underdeveloped, unjust, and dangerously unstable.

Stern’s central argument rests on the idea that prevention, or “mitigation”, of climate change is possible, and cheaper than “adaptation”, or trying to deal with the consequences. The cost of mitigation is about 1% of GDP per annum over fifty years. There is no real attempt to assess the cost of adaptation, and because Stern says very little about the process, it is difficult to know what the comparison is based on. Two criticisms have been made of Stern. One is that he does not discount adequately – he gives far too much weight to an uncertain future, counting future generations as worth nearly the same as present generations. Because future generations always outnumber the present, this kind of argument can always be used to show that prevention of unpredictable, remote events is worthwhile. The second problem is that he gives far too little weight to the poor, both now and in the future. Stern does accept that the poorest people will be hit first, and hit hardest. If Stern is right, there are major issues looming relating to water supply, agricultural production and the migration of 200 million deprived people. I do not know how much they will cost either, but a forty or fifty year programme of development, resettlement and relief could do a great deal to reduce the harm that the report foresees, and if the numbers of people are those outlined in the report, the money earmarked by Stern for “mitigation” should be more than enough to lift those people out of poverty. It might be prudent to start paying a little more attention to those issues now.

Further note, 1st April 2014:  I returned to this blog entry  following the publication of the IPCC’s draft report, snappily named WGII AR5.   I’m pleased to say that the IPCC have started, at last, to take ‘adaptation’ seriously.

 

Two parents?

What is a parent? Is it a biological relationship? Or is it someone who raises and nurtures a child? In the UK, we have tended to assume that the two things mean much the same.

  • People with a biological relationship are expected to take responsibility for their children; people whose relationship is social are not.
  • Someone can show they are a parent by a DNA test. They can show they are not a parent by a DNA test.
  • Where a biological father has nothing to do with a child, that parent can be pursued. Recently, this has been extended to cover anonymous sperm donors, who have been arraigned for child support.

There is nothing inevitable about the idea that parenthood is biological. In France, parenthood is understood in social, rather than biological terms. When a child is born, it can have no parents, one parent, or two. If the mother or father do not accept the child, the child will have only one parent. If both of them withdraw, the child is treated as having no parents, and may be adopted.

One of the central assumptions behind the structure of family law in the UK is that children have two parents. The norm is both an expectation, and a rule. Where it does not apply, it is treated as if it ought to apply. So,

  • When a couple separate or divorce, there is a general presumption that both partners will have access to the children. This applies not only for biological parents, but for subsequent partners, who may be able to establish rights of access.
  • Where a child has no parents, people who want to adopt are expected to be young couples – which means that most of the people who hope to adopt are not allowed to do so.

The assumptions behind these policies are increasingly questionable in practice. The first, and most obvious thing, to say about them is that many children do not have two parents. In a society where many children are born to unmarried couples, and many marriages end in divorce, they tend to have a relationship with one carer, rather than two. About 40% of all children do not see the absent partner at all two years after a divorce. The preoccupation with biology, the insistence that children must have two parents, and the under-estimation of social relationships, is at odds with experience. More importantly, they are often at odds with the interests of the children.

There is little prospect of bringing about a fundamental cultural change, and no prospect at all that a law modelled on the French idea could be implemented directly in the UK. But there are several principles we ought to consider. They would include

  • the acceptance that a child can have only one parent.
  • the consequent normalisation of adoption by single parents, or by one person within a couple. The central principle should be the child’s best interest, and it is not in a child’s best interest for there to be a custody battle when couples separate, and
  • the identification of parenthood as a social responsibility.

We need also to balance the position of children who have more than two people in parental roles – mainly through step families. The law has been gradually amended to recognise the importance of these relationships, and partners may have rights of access; but we should not be confusing those rights with the rights of parenthood.

Old people in crisis

The maintenance of old people in their own homes for as long as possible has been an objective of community care policy since at least the 1960s. A Ministry of Health circular stated in 1962 that:

“Services for the elderly should be designed to help them remain in their own homes for as long as possible.” (1)

There is, however, a concealed implication in the policy. The implication is that the time may well come when it is not possible. The idea of care in one’s own home is based in a dichotomous model of care, in which people receive care either in their own homes or in some kind of institution. The effect has been to postpone relocation into residential care or purpose-built accommodation until the old person faces some kind of crisis, when it is difficult to adjust to changes in circumstances. For many old people, the effect is the reverse of promoting independence: they are forced into situations where they have no option but to become dependent. Half the people coming into residential care come from hospital, because they cannot return to their own homes; decisions to enter residential care are largely taken not by the old people themselves, but by professionals or carers.

There is a dilemma in the aim of promoting independence. Independence is generally taken to mean non-intervention and non-dependence; people are independent for as long as they do not depend on others for their care. People preserve independence, consequently, by refusing services until they can refuse them no more. There is something deeply wrong with this concept of independence, and it might be helpful to start using another, slightly less tainted word: the idea of autonomy. People act autonomously when three conditions are satisfied: they are able to make decisions for themselves, they are not constrained, and they have options to choose from.

We should not be looking, then, to keep people in their own homes for as long as possible, because that is the route to crisis. We need to be thinking, instead, about how people’s autonomy can be maintained to the greatest possible extent. One option is not to offer care in someone’s original home, but to think of more flexible and varied residential provision. Core and cluster units, or “very sheltered” housing, bring people close enough to services to make it feasible to deliver long-term continuing care without a further move. If old people are encouraged to relocate, not at the latest possible point, but at the earliest, they can settle, form relationships and communities, and have a reasonable chance of maintaining their situation without having to move on later. Moving as early as possible is the exact opposite of care in one’s own home for as long as possible. It is not right for everyone – no policy ever is – but it has a great deal to commend it. Moving early increases independence, broadens choice and minimises disruption of the most vulnerable. Moving late reduces independence, denies options and puts people at risk. This policy is long overdue for a rethink.

Note 1. 2/62, Development of Local authority health and welfare services.

Genetic arguments and social policy

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 (1), 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. (2) 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.

Note 1. S Jones, 1993, The language of the genes, London: Flamingo, ch 12.
Note 2. See R Lerner, Final solutions, Pennsylvania State University Press 1992.