Testing treatments

There are lots of reports that “faith in God really can relieve pain” and such in the press at the moment. These reports are based on a study published in Pain (yep, medical journals have all the most exotic titles: Gut, Brain, Breast, Lung….) and the abstract is available here.

Unsurprisingly, the research does not prove anything about a faith in God relieving pain. What does it show, then? The researchers compared 12 practising and believing Catholics with 12 nonbelievers. The researchers administered electric shocks to the subjects’ hands while asking them to study either a religious picture of the Virgin Mary or a secular image. When the groups were compared, the Catholics studying the image of the Virgin percieved that they had less pain. This correlated with specific findings on functional MRI scans which the researchers thought could play a role in brain regulation of pain in this group. 

This is interesting, but it does not prove that faith in God has reduced pain. It shows that pictures of the Virgin Mary, presented to people likely to be familiar with that image, caused reductions in those people’s perceived pain. It may have been the case that any familiar image – religious or not -  would have been as capable of distracting people from pain.

That is worth exploring. While distraction is a well known technique for helping with pain, more work may help sort out what kinds of visual distraction work best for what people.

The first time I heard about neuro-linguistic programming, I was intrigued. By scrutinising and changing a person’s speech and body language, NLP promises to improve social and professional interactions.

It has, we’re told, the power to “unlock your capabilities”. Negative psychological patterns are identified, and can be “reprogrammed”. Sensitivity to others’ behaviour is also heightened. Indeed, by showing me how to “read” unconscious behavioural signs, it could allegedly help me be a better doctor.

The technique has been around since the 1970s. Its methods have been described enthusiastically in publications as respectable as the British Medical Journal, while the Royal College of General Practitioners is running NLP “master classes”. The course blurb says: “Neuro-linguistic Programming is the study of human excellence, in terms of how we can learn to take control of our consciousness … We know that an optimistic outlook and good emotional management improve health so it is important to teach others (and ourselves) how to change limiting beliefs and attitudes to restore health and maintain happiness.”

The remainder of this column can be read here. Please post comments below.

What happens when NICE says no? If NICE refuses to fund an expensive intervention to treat cancer, but the patient wishes it anyway, the patient must forgo all ‘free’ NHS care and pay for the intervention, plus all the rest of their care – ie be subsequently treated entirely as a private patient. Care then becomes very expensive.

There has been a lot of debate about this recently, with many arguing that this is wrong, and that patients should be allowed to pay for ‘top-up’ care for whatever additional treatments they may wish to have.

Freedom of choice is obviously desirable, but, as I’ve argued before, it has to be a meaningful choice. It is incredibly hard to look at newly generated evidence and to try and decide what it means for one as an individual. This becomes even harder when the data is 1) not free to access in its entirety 2) not yet peer reviewed (eg selected data being presented at a conference) 3) presented in ways where the best possible interpretation of the treatment is used (e.g. outcomes described as a reduction in relative risk rather than in absolute risk)  4) when the trial has been small scale and/or short term, which, among other things, may not be long enough or large enough for significant outcomes or adverse effects to be made apparent.

Lots of media coverage on a new study today, which is apparently going to compare the reported offences of prisoners while taking either placebo or a fish oil+multivitamin+mineral supplement. Some headlines  have interpreted this as ’Prison study to investigate link between junk food and violence’. I think that’s an extrapolation too far; the quality of the food the people eat isn’t going to vary during the study (although nourishing food, and the social interactions of eating should perhaps be an area of further interest in this group of people.)

The apparent health improving qualities of fish oils have been much overhyped in recent years. However there have been previous studies done looking at the effects of fish oils in prisoners and good quality evidence on a larger scale is to be welcomed. I haven’t seen the trial protocol on the register yet, but will keep an eye on this story.

Just as I was working out how to play a Harry Potter DVD an amazing television advert came on. It’s only broadcasting in Scotland but you can see clips at Get randomised. The website doesn’t say who is funding the ads, but I am impressed at the way that fair clinical trials are being promoted as a good thing and not, as per usual,  mad scientists coercing gullible victim human guinea pigs into crazed experiments.

What would be very nice would be a study to assess the impact (or not) of these adverts – fair tests for all interventions, indeed…

Moan as we do about the National Institute for Clinical Excellence (NICE), which decides which drugs should be available on the NHS, the idea that there should be a rationale about rationing has been received rather differently across the Atlantic.

In the US $2,000bn is spent annually on healthcare, but only 0.1% of this is actually used to assess whether any of the money was spent wisely, the BMJ reports this week. Two Democratic senators have introduced a bill, which has been generally welcomed, to establish a NICE-like institution to evaluate what the most effective healthcare interventions are. 

The responses to the piece below about NICE’s proposal not to fund new drugs for renal cancer are, in disagreement, understandable. But the problem is that rationing healthcare interventions is inevitable. Even if we (rightly) save money by stopping inappropriate prescribing and other ineffective interventions, there are still going to be limits and hard judgment calls to make. These decisions should be made openly and as fairly as possible.

Pretty soon, it might well make more sense to ask who isn’t on statins, rather than who is.

More than three million people are estimated to take these cholesterol-lowering pills – mainly to help reduce the risk of heart disease – and recent plans to offer everyone over 40 a cardiac risk assessment could more than double the figure. Statins can be bought over the counter, and the NHS spends £500m a year on them. That makes them the biggest single item on the health service’s shopping list.

The remainder of this column can be read here. Please post comments below

It was reported today that East Lancashire Primary Care Trust have a plan to deal with overweight schoolchildren. When the children return to school after the summer holidays they are to be weighed, and, if overweight, apparently they and their families will be ‘cold-called’ by nurses, who will then encourage them to lose weight.

But how? I’m sure the intentions behind this scheme are good ones. But I can’ t help wondering how evidence based this scheme is. The Cochrane Library contains information about  interventions for reducing obesity. Essentially “there is a limited amount of quality data on the effects of programs to treat childhood obesity”. In terms of prevention, another Cochrane review says that “There is not enough evidence from trials to prove that any one particular programme can prevent obesity in children, although comprehensive strategies to address dietary and physical activity change, together with psycho-social support and environmental change may help”.

My concern is not just that I loathe pushing unsolicited medical advice. It is also that all medical interventions contain the possibility of harm. We don’t know whether children will be stigmatised or totally turned off by this kind of intervention. Additionally, the resources may be better used elsewhere to pay for decent and exciting play parks (I am always sad when the tiny patch of grass in housing estates is marked with ‘no ball games’ signs), safe road crossings to walk to school, or free good quality school lunches for all. But without considering what the evidence tells us, and trying to address these and their multiple uncertantites, we are not going to be doing anyone any favours.

There’s an interesting comment piece by Professor Mary Dixon-Woods in the Lancet Oncology this week. The ‘Research Ethics Committee’ approval, which is required before a clinical trial can begin, has been criticised by some doctors as being too slow, too burdensome, and inconsistent. The concern has been that the process of gaining ethical approval for a study is, amongst other things, so bureaucratic that important questions about treatments are not being asked, because it is too hard to get permission to do so. This comment piece looks at the reasons why Research Ethics Committees decide not to approve trials. The major reason, the authors found, was to do with informed consent. In some cases, the REC was concerned that the trial was couched in overly enthusiastic terms, eg a patient information sheets said ‘we hope that participation in the trial will help you by providing the best available treatment for your cancer’.

This is especially interesting, particularly given the recent coverage of the prostate cancer drug abiraterone (see blog post below.) So far, there is one published clinical trial; a study of just 21 men. How are patients going to feel about entering into a trial where they may not get this (overly hyped) drug?

The problem with so many ‘wonder drugs’ is that one is prone to wonder drug fatigue. So is the new prostate cancer drug, abiraterone, lauded on so many front pages today the real thing? “Cancer drug could save the lives of 10,000  a year” says the Times, and it’s a big ‘could’. 

It’s a bit unusual for a study containing only 21 patients and which is in the initial stages (phase I) of testing as a treatment to receive such widespread and enthusiastic publicity. Apparently there was a briefing for journalists (not usually the case for releasing research) which probably contributed to just so many headlines. There are, after all, thousands of small studies published in thousands of medical journals across the world ever week. While some of the comments made by some people approached for views on the study are rightly cautious, I am still concerned that there appears to be an awful lot of enthusiasm about a drug that really is still in the initial stages of its assessment. 

The abstract for the paper is here.  And a conflict of interest: I found at least two more things declared as wonder-type-drugs in the papers today, and I don’t believe in wonder drugs.

Margaret McCartney’s Blog

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A forum on healthcare policy and professional issues, by Glasgow-based GP and FT Weekend columnist Margaret McCartney.