Effectiveness

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 This becomes even harder when the data is 1) not free to access in its entirety 2) not yet peer reviewed (eg selected data being presented at a conference) 3) presented in ways where the best possible interpretation of the treatment is used (e.g. outcomes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.

Hospital acquired MRSA infections in the UK have apparently fallen by a third in the last year according to the Health Protection Agenc y. Gordon Brown is writing to all NHS staff to say well done.

I foresee problems. There have been a couple of political drives on MRSA recently which have been non-evidence based; the ‘deep clean’ of all hospitals and a ban on long sleeves for staff (even though the Department of Health itself said this was non evidence based.) In fact, the nonsense spoken by the DoH demonstrates the absurdity of how MRSA is being dealt with. On one hand the Uniforms and Workwear policy they have produced keeps saying how important it is to look professional (no untied long hair, not ‘too many’ badges) because this could ‘send the wrong messages’ to patients about ‘professional pride’. At the same time, while acknowledging there is no evidence for it, the policy bans neck ties.  I know of hospitals expending considerable energy into banning cufflinks while doing precious little about their commodes being shared. There is no evidence that any of the government’s ideas have had anything to do with a decreased rate of MRSA infections. The danger is that the government believes its own hype and that its policies have made the difference.

I wrote about microbiological concern about MRSA transmission last year here. The things that do seem to make a difference to MRSA infections are antibiotic prescribing, the cleaning of all surfaces, especially the less obvious ones, and decreased bed occupancy rates. Banning neck ties is not only non evidence based but it is not the surface most able to come into contact with most patients either. What about blood pressure cuffs, stethoscopes, curtains around beds, and visitors?

Would anyone like to help the cause of homeopathy? There is an interesting job description in the British Medical Journal this week. It is for both an expert and a lay person to ‘contribute actively’ to the Advisory Board on the Registration of Homeopathic Products. The pay is £275 a day, and they have 11 meetings a year.

 It is tempting to ask how many thousands of pounds the goverment are spending on this exercise. It is even more tempting to ask how, possibly, the Board can function. Any other medicine that the Medicines and Healthcare Regulatory licenses has to have evidence of it’s efficiacy and safety. The members of this committee will have to “give advice about safety and quality” on substances that don’t actually have proof of working.

If any FT readers are up to the challenge of bringing some sense into the boardroom, please do let me know how you get on.

There are yogurts with cholesterol-reducing properties and other dairy products which can supposedly produce “optimal” bowel health. Then there are baked beans with “added omega threes” and drinks that profess to reduce blood pressure. The European Food Safety Authority is now providing “opinions” on the science behind such claims. However a lot of the claims seem to rely on evidence about surrogate markers (eg a product may reduce cholesterol, however what we do not know if this method of reducing cholesterol will go on to have an effect on avoiding heart attacks or stroke.) 

In the end, I suspect that there will not be many adverts rivalling the qualities of ordinary fruit and vegetables –  generally for sale without much in the way of flashy health claims.

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.

Pharmacists were reportedly delighted with a new scheme, just announced, to allow for azithromycin, an antibiotic, to be made available without a doctors’ prescription. This drug is a treatment for the sexually transmitted infection Chlamydia. Since Chlamydia infection can be without symptoms, and since, if it is left untreated over time, it can lead to problems such as inflammation and infertility, the idea has been to try and treat as many infections as possible before they cause problems.

This sounds sensible. But as usual the truth is a bit more complicated. This new prescription-free service is part of the Government’s strategy on dealing with sexual infections, and it hinges on screening for Chlamydia. Crucially, testing for this no longer needs an internal examination and swab to diagnose it. Instead, Chlamydia infection can be identified on a urine sample. This means that a doctor or nurse to do an internal examination isn’t needed, and that a urine sample can be tested. If positive, the infection can be treated with the over-the-counter azithromycin, and without a doctor.

This approach increases the amount of places to get a diagnosis and access to treatment. But the problems are multiple. There is a lot of concern that in offering only testing for Chlamydia, other sexual infections will go undiagnosed. Doctors are frequently reminded that other infections, initially without symptoms, can be sexually transmitted, particularly HIV and Hepatitis B. Indeed, at least some of the problems resulting in these infections not being diagnosed as early as they could be has been because of the (sometimes understandable) reluctance of healthcare professionals to raise the issue of testing for something which carries a stigma. However, earlier diagnosis brings many benefits, and stigma may simply have been perpetuated by medical reluctance.

But the other issue is whether this scheme will result in more diagnoses of Chlamydia. The ‘approved standard testing kit’ costs £25, and the antibiotic to treat a positive result costs £20. Since testing is free, meantime, on the NHS, and the prescription for a positive result available for either cheaper or free, I am not sure that this new innovation will prove the answer for over-stretched services, as claimed. Indeed there is still considerably dubiety about the effectiveness of opportunistic Chlamydia screening in general. Health economists have pointed out that on current evidence, it does not appear to be cost effective.

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.

Sex sells. I suppose this is why the results of a study entitled ”Sildenafil Treatment of Women with Antidepressant Associated Sexual Dysfunction” were reported with great enthusiasm around the world after they were published in the Journal of the American Medical Association (Jama). Yet the study is interesting for a number of reasons.

Rest of column here.

Prostate cancer screening via use of a PSA (prostatic specific antigen) testing – a biological marker found in blood – is one of the most contentious things around. There is no such contention over seeking diagnosis and treatment for prostate symptoms. It is screening for problems when no symptoms exist that is the issue.

While the logical view may be that ‘catching things early’ is a good thing, the truth is rather different (I am getting deja vu: exactly the same thing applies to breast self-examination). PSA testing is even messier, though, in terms of potential harms. A high PSA result can be a false positive for cancer (instead inflammation or a benignly enlarged prostate can cause high results) or false negative (PSA is not elevated where there is prostate cancer present). Additionally, the surgical treatment for prostate cancer can result in major side effects (impotence and incontinence). The crux is, that for prostate cancers found at screening, there may be no benefit to the man in question in improving mortality, but there still may be harm done in terms of ‘treatment’.

While in the UK prostate cancer screening is not routinely done, in the US there is a culture that says ‘all men must know their own PSA’, despite the lack of evidence for this. However, today the US Preventive Services Task Force has said that “Current evidence is insufficient to assess the balance of benefits and harms of screening for prostate cancer in men younger than age 75 years” and “Do not screen for prostate cancer in men age 75 years or older”. There are trials ongoing which will hopefully give us better information, but in the meantime, the circumspect approach in the UK (where generally more information given about the limitations and potential harms of PSA screening leads to a decrease in the amount of men who end up having it done) looks like it is the right one.

One of the medical newspapers, Pulse, has a news article saying that there has been a drop in the number of  homeopathic prescriptions by GPs in the UK. In 2005, there were 83,000 written, and in 2007, it had fallen to 49,300.

This is good news. It could be that GPs are becoming more critical about the evidence for their prescriptions, or patients are being more critical of the evidence for what works. One UK NHS homeopathic hospital has had funding withdrawn. The National Institute for Clinical Excellence evaluates interventions and recommends that treatments of marginal or no cost effective benefit are not funded. However it is most unfair that homeopathy, which the evidence says doesn’t work beyond that of placebo, has yet to undergo a similar evaluation.

Having said that, homeopathy does have a placebo effect,  a valuable thing. The placebo effect could be regarded more broadly as the beneficial effects of medicine which are not mediated by a biologically active ‘medical’ intervention itself – placebo pills and even placebo surgery have been found to have beneficial effects for patients. So have, for example, continuity of care, and longer appointment times. The ethics of using placebos are fraught. However, there is no such ethical problem with providing longer appointments and continuous care. It seems most unfair that the  people currently allowed to benefit most from the placebo effect are those who are prepared to use homeopathy. There are other, better things that could be used for more people to benefit from such ‘caring effects’.

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.

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