A few years ago I stumbled across the works of the “General Semanticists“. I won’t go into detail about this school of thought here, but it originated with a man called Alfred Korzybski in the early years of the 20th century. He wrote and taught about the way in which human beings reacted as whole organisms to their environment. One of the most interesting features of this way of thinking is the emphasis it gives to not only environment, but to what Korzybski called the “meaning environment” – in other words both symbols and the symbolic power of the environment itself. This focus raises all kinds of issues including change, transience, and context. The book which made this whole way of thinking clear to me was Samuel Bois’ Art of Awareness (ISBN 978-0965103701).

One of the ways of thinking they highlighted for me was “two value thinking” – we do this a lot. It’s the process by which we classify experience into one of two categories – us and them; black or white; and so on. Although generalisation and categorisation can be useful tools they are dangerous and frequently stop us seeing reality. You’ll come across this a lot in medicine. I’m sure you’ll have heard people talk about treatments as either “proven” or “unproven”; “evidence-based” or “not evidence-based”; “drugs which work” and “drugs which don’t”. But this is a silly and unhelpful way to think about treatments because all treatments need to be considered within the inescapable context of the individual. And you can’t even say a treatment “works” or “doesn’t work” for an individual – the same treatment can work at some point for a person, but then not work at another.

Think about painkillers as a simple example. Is there a “proven” painkiller which will kill pain for all individuals on all occasions? No. And, actually, it’s the same with all medical treatments. The only person who can tell you whether or not a treatment is beneficial for them, is that person – doctors have to listen to their patients and hear what their experience is. It’s very frustrating for patients to be told by a doctor that their lack of benefit they’ve received from a particular treatment is their own failure – because the treatment is “proven”. Similarly, it’s very frustrating for a patient to be denied a treatment which brought them benefit because somebody has ruled, on the basis of clinical epidemiology, that that particular treatment is “not evidence-based” or “does not work”.

The world is more complex than that. See if you can spot any two-value thinking today, and consider different contexts to see the weakness of this type of thought.

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What’s the point of health care? Does that seem like a question with an obvious answer? It would be reasonable to expect that the answer would be that health care is about caring for people’s health. But that’s an answer which is not really an answer. It raises the question, what is health? Stop and think about this for a moment, because it’s not a straightforward question to answer. My answer is that health is a phenomenon in its own right – it is NOT the mere absence of disease. It has distinct characteristics – adaptability, creativity and engagement. Others will have other answers, other characteristics to add, other qualities. It’s difficult to extricate health from the old concept of “eudaimonia” which tends to be translated as “happiness”, or even “wellbeing”, but I prefer the word “flourishing”. Surely health is about flourishing? The less we flourish, the less we rate ourselves as being healthy, well, or good.

This way of thinking about health is holistic. It demands that we consider the whole of a person’s life, and by that I mean the whole of their present time life (a biopsychosocial approach), and the whole of their life from start to finish. This has at least two consequences. Firstly, it means that all health care must take into consideration, not just objective disease in the form of pathology or lesions, but it must consider the individual patient’s story. No two patients have the same life, and therefore, no two patients share the same experience. With the same disease, two people will experience different symptoms and those symptoms will mean something different to each of them. In addition, each individual will have their own ways of coping, adapting to and dealing with their illness. Health care needs to relevant to the individual who is being cared for.

Secondly, it means that health care interventions will alter the experience and course of a person’s life, but they do not, ultimately, prevent death. The overall mortality for human beings is 100%. We do all die. But much of contemporary health care is predicated on the basis of death avoidance. We are bombarded with claims about “life-saving” medicines and Public Health policies which claim to reduce death rates. Statins, for example, are even promoted for healthy people, to reduce their risk of death from heart attacks and strokes. Whilst nobody would really like to have a heart attack or a stroke, no-one is asking the question, what do people who would have died from a heart attack or a stroke die from instead? The focus is on death avoidance. People are classed as being “at risk” – at risk of dying from disease x. But to make an informed choice about a treatment don’t you need to have an idea of the possible and likely consequences of that treatment? To say a treatment reduces your risk of dying from disease x is all very well, but it doesn’t say much about whether or not you’ll experience a life of greater flourishing. Especially if you develop another more disabling, painful condition instead. The logical extension of this death avoidance thinking is to try to avoid death from all causes. For example, some doctors and scientists have promoted what they call the “polypill” – a combination of drugs all in one pill, which, if taken by the whole population (or in this case the whole population over the age of 50), would significantly reduce the death rate from cardiovascular disease. Well, if you don’t die from cardiovascular disease, what do you die from? Cancer? Nervous system disease? Liver disease? Blood diseases? There’s no way to know of course but isn’t it true that it will be something else? Or do you think healthy people die disease-free?

It’s likely that a person will fight hard for life at all times. (Well, not everyone, as Dylan Thomas wrote, “Do not go gentle into that dark night. Rage, rage against the dying of the light.” exhorting his father to fight for life at the end of his life). Around a third of all health care expenditure is on people in the last year of their lives. (see New England Journal of Medicine 1993:328:1092-6 for example)  You might hope to live three score years and ten, and if you do, you can expect that most health care you receive will be in your last year of life. Think of it this way – assuming 70 years of life (I know, that’s quite an assumption!), one third of your health care will be in one seventieth of your life and two thirds for the other sixty-nine seventieths. Why is that? Because you can expect to flourish for 69 years and suffer for one? I’m not sure that’s most peoples’ experience. If health care is about improving life as opposed to merely trying to avoid death why don’t we direct more of it to life instead of death avoidance?

It seems that our so-called “health care” isn’t focussed on health at all. It’s focussed on death avoidance. That was the goal of the alchemists – the elixir of life which would produce immortality. But that’s a myth isn’t it? Shouldn’t we have health care which is more realistic? After all, if we do address illness holistically, reducing suffering, encouraging healing, resilience and growth, aren’t we likely to also increase the length of life? Might that not be a better way to avoid “premature deaths”?

Maybe we should be concentrating on increasing health, in a eudaimonic sense, instead of concentrating on avoiding death, which, realistically, is ultimately impossible.

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It kind of annoys me how some illnesses are considered “real” and some not – fibromyalgia is one of those controversial disorders which some doctors dismiss as depression simply because the patient is down (who wouldn’t be with daily pain??) and because none of the tests show anything abnormal. It will probably turn out that this is one of those cases of looking in the wrong place. Because the pain is felt in the muscles, doctors have tended to look at the muscles. And they don’t find anything abnormal. So they look at the joints, or the tendons, ligaments and soft tissues around the joints. Nope, still don’t find anything wrong.
Well, here’s something interesting from France -a team of researchers have found consistent abnormalities in brain function in patients with fibromyalgia. Specifically, they’ve found abnormalities of function in distinct areas of the brain independent of the patient’s depression score. Here’s what they found –

The researchers confirmed that patients with the syndrome exhibited brain perfusion abnormalities in comparison to the healthy subjects. Further, these abnormalities were found to be directly correlated with the severity of the disease. An increase in perfusion (hyperperfusion) was found in that region of the brain known to discriminate pain intensity, and a decrease (hypoperfusion) was found within those areas thought to be involved in emotional responses to pain. In the past, some researchers have thought that the pain reported by fibromyalgia patients was the result of depression rather than symptoms of a disorder. “Interestingly, we found that these functional abnormalities were independent of anxiety and depression status,” Guedj said.

The authors go on to conclude –

“Fibromyalgia may be related to a global dysfunction of cerebral pain-processing,” Guedj added. “This study demonstrates that these patients exhibit modifications of brain perfusion not found in healthy subjects and reinforces the idea that fibromyalgia is a ‘real disease/disorder.'”

I do think this is good news. It means that doctors are beginning to discover something about what kind of disorder fibromyalgia is. But I do despair about this continued categorisation of disease into “real” or not. (with “not” usually being categorised as mental illness) Mental illnesses, such as depression, should be diagnosed in their own right, not as what’s left over after a battery of tests are returned with “normal” stamped on them!

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In an excellent article in the BMJ, Nicholas A Christakis, professor of medical sociology at Harvard, asks the questions all doctors (and their patients) should be asking. He points out that too often these days we misunderstand (or maybe misuse) the results from drug trials.

Doctors say that a drug “works” if, in comparison with the control arm of a clinical trial, significantly more people in the treatment arm respond. Unfortunately, this is a naive oversimplification, and it breeds complacency among patients and physicians alike

He points out that it is frequently the case that a drug which is shown in trials to help more patients than a placebo or other treatment, very often actually only delivers this benefit for the minority of patients who are actually prescribed it. I’ve quoted Dr Roses of GlaxoSKF a few times on that same point!

Countless drugs that have been shown in randomised controlled trials to be effective work in only a minority of patients. Imagine that a drug worked 20% of the time in a trial, compared with 5-10% for a placebo. This is the case for drugs ranging from antihypertensives to minoxidil to cancer chemotherapy. Such a difference in a trial corresponds to an enormous effect size. However, most patients taking such drugs would not benefit—they would hardly think that the drugs “worked.” If you buy a toaster you expect it to be able to toast bread every time it is used. If it does not, you say it does not work and return or discard it. You do not take solace from the claim that, in fact, 30% of the time in the manufacturer’s laboratory the toaster did a better job in browning bread than sunshine alone.

It does amaze me that certain treatments are labelled “proven” in this way. What’s even worse though is when the prescribing doctor then seems to blame the patient for their “failure” to respond to the treatment. This leads me on to the author’s recommendation –

one appropriate reaction is to have a protocol of administration that evaluates a patient’s response. Doctors sometimes already do this in a systematic way (such as when titrating the administration of highly active antiretroviral treatment). But this practice should be more widespread and more formal

Whilst I agree with this recommendation, it still does amaze me. Don’t all doctors routinely check how every individual patient is doing?

Anyway, here’s the take home message, in the last paragraph of the article –

Just because drugs work in trials does not mean they will work in our patients. In fact, we can often expect that they will not work at all.

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There’s quite a trend in recent years towards Public Health measures centred around what you might call “technical fixes” – the idea that a technology of some kind can improve health. The technology of choice, of course, is pharmacology and we are bombarded with messages that various different drugs should be taken by increasingly large proportions of the population in order to achieve greater Public Health. I think this is a myth. It’s part of the larger myth that science and technology will allow us to control Nature, to set out how we would like life to be and to achieve those goals. There’s an awful lot of sloppy thinking on this subject. Quite often we are told that a particular drug has the ability to be “life saving”. Drugs don’t save lives. At best they alter the death experience, but everybody dies from something and drugs actually don’t let you be sure that YOU, the individual YOU, can avoid a certain kind of death.

Take death from heart disease and strokes for example. We’ve been told that everyone should take aspirin because if everyone took aspirin then a lot less people would die from heart attacks or strokes. Listen carefully to that advice because it is a statistical statement – if MOST people took drug x then LESS people would die from y. That’s not the same as saying that if YOU took drug x then YOU would be less likely to die from y. The difference might seem subtle but it’s significant. The difference is ignored by people who suggest that we are all the same and we should all follow the same course of action. For example, a few years back some doctors and scientists promoted the idea of a “polypill” which every adult should take so that the death rate from certain diseases would be reduced. (what the authors didn’t seem to think about was what, if they were correct, would all these people die from instead? Don’t you think that matters?)

In this week’s BMJ there is an editorial summarising the studies of populations taking aspirin and their conclusions are clear.

These result support the concept that risk assessment alone cannot predict which patients will benefit from aspirin. In fact, the only predictor of clinical response to aspirin is a history of a major coronary or cerebral ischaemic event, as defined by the previous meta-analysis

In other words, there is only a statistical benefit from aspirin in patients who have already experienced coronary or cerebral ischaemic disease (that’s angina, heart attacks or strokes primarily). In the population who haven’t experienced one of these diseases there’s no benefit from taking aspirin.

Buried in the text of the article is this statement too –

However, not all patients with cardiovascular disease respond to aspirin, as shown by a recent meta-analysis of aspirin trials in peripheral artery disease

So beware of taking these messages at face value. It seems that only those who have already developed cardiovascular disease may be helped by taking aspirin and of these not all will get the benefit.

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I’ve wrestled with trying to understand what health is – in fact, I often challenge doctors I teach to come up with a definition of health which makes no reference to disease or illness. Sure, WHO’s definition does say that health is more than the “mere absence” of disease, but that still doesn’t quite capture it. I think the three qualities of adaptability, creativity and engagement are good ones to consider when grappling with this concept called health.

But there’s another word doing the rounds now – “wellness”. Was does “wellness” mean to you, and does it mean something that “health” doesn’t?

Whatever definitions you come up with, I bet it doesn’t include what I just read about a new technology – a test card which, using a single drop of saliva or blood, can check for the presence of a bank of diseases.

I’m sorry, but that’s a “sickness card” not a “wellness card”! Even if it could test against 20 diseases, it will only tell you that you don’t have one of those 20 diseases – and that does not make you “well”!

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Sir Michael Rawlins, Chair of the National Institute for Health and Clinical Excellence, has recently criticised our use of RCTs (Randomised Clinical Trials). This particular type of research study is promoted by many decision makers as a “gold standard” but Sir Michael listed a number of objections to this practice. He gave examples of situations where RCTs are either unneccessary or impossible, questioned the practice of failure to complete studies (30% of recent trials in oncology have been stopped early because of apparent benefit from the treatment), and expressed his concern about the high costs of conducting such research. However, perhaps his most interesting remarks related to the generalisability of RCT findings and the elevation of this methodology above others.

RCTs are often carried out on specific types of patients for a relatively short period of time, whereas in clinical practice the treatment will be used on a much greater variety of patients – often suffering from other medical conditions – and for much longer. There is a presumption that, in general, the benefits shown in an RCT can be extrapolated to a wide population; but there is abundant evidence to show that the harmfulness of an intervention is often missed in RCTs. Sir Michael argues that observational studies are also useful and, with care in the interpretation of the results, can provide an important source of evidence about both the benefits and harms of therapeutic interventions. These particularly include historical controlled trials and case-control studies but other forms of observational data can also reveal important issues. Sir Michael rejects the trend to grade various kinds of clinical trials and studies on scales of merit which he says has come to dominate the development of some aspects of clinical decision making. “Hierarchies attempt to replace judgement with an oversimplistic, pseudo-quantative, assessment of the quality of the available evidence.” Sir Michael believes that arguments about the relative importance of different kinds of evidence are an unnecessary distraction. What is needed instead is for “investigators to continue to develop and improve their methodologies; for decision makers to avoid adopting entrenched positions about the nature of evidence; and for both to accept that the interpretation of evidence requires judgement.

The generalisation issue has been raised so often it’s surprising that it is dismissed so easily by decision makers. Not only are trials artificially created clinical experiences but the entry and exclusion criteria for patients admitted to such trials always excludes “co-morbidity”. In other words if somebody had more than one clinical problem they won’t be admitted to the study. However, in actual clinical practice patients presenting with more than one disease at a time occurs so frequently that it is considered usual. Other criteria also make it difficult to generalise the results of RCTs. But, Sir Michael’s main criticism is about safety. The problems with a new drug are rarely picked up by RCTs. The problems indeed are not usually evident until many more patients have taken the drug in real life circumstances. So if we want to understand the real life potential of a drug, then we need larger, observational studies to pick up the side effects and harms which the drug can cause.

His final point is about the use of “hierarchies of evidence” which give greater credence to some methodologies over others. His contention that this distorts both the nature of evidence and that it is used as a substitute for clinical judgement is an important one

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I read some research recently linking low vitamin D levels to chronic pain in women. As the Scottish population is well known to be rather deficient in vitamin D (not enough sunlight, poor diet), and as I see a lot of patients with chronic pain, I’ve started sharing this research with female patients who have chronic pain. Already I’ve had back reports of quite dramatic reductions in pain levels in some of these patients. I hadn’t been aware of such a connection before but I had been aware that vitamin D insufficiency might be one of the factors behind the high levels of Multiple Sclerosis in Scotland. Well, it seems that vitamin D may have an even more extensive role to play in health than we realised

In a paper published in the August issue of the American Journal of Clinical Nutrition, Norman identifies vitamin D’s potential for contributions to good health in the adaptive and innate immune systems, the secretion and regulation of insulin by the pancreas, the heart and blood pressure regulation, muscle strength and brain activity. In addition, access to adequate amounts of vitamin D is believed to be beneficial towards reducing the risk of cancer. Norman also lists 36 organ tissues in the body whose cells respond biologically to vitamin D. The list includes bone marrow, breast, colon, intestine, kidney, lung, prostate, retina, skin, stomach and the uterus. According to Norman, deficiency of vitamin D can impact all 36 organs. Already, vitamin D deficiency is associated with muscle strength decrease, high risk for falls, and increased risk for colorectal, prostate and breast and other major cancers.

This research group is recommending that people take 2000 international units of vitamin D a day. This is considerably higher than other recommendations which range from 200 to 400 units depending on age (older people need more). It is possible to take too much vitamin D and be harmed by it but this is unlikely at doses under 10,000 units daily so the 2,000 units recommendation is well within safety limits.

This seems to be a developing story, but I think we’re going to see more attention being paid to this somewhat neglected vitamin!

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