Beyond the Bounds of NICE

A long time ago, in the early years of my ME, a small study in The Lancet suggested that intramuscular magnesium injections could be beneficial for CFS (as they called it). I took a copy of the study to show my GP, the late Dr Paul Moxon here in Leeds, UK, who read it and started injecting his ME patients in line with the study protocol. In a matter of a few weeks, I went from being largely housebound to up and about again. I made this transition gradually but it is worth recording, by the by, that any deconditioning which might have occurred while I was being looked after by my parents for several years did not present any significant impediment to my remobilisation. When my body got what it needed, I was able to function again. I was by no means cured but the improvement was substantial.

Since then, my ME has fluctuated and at one time I became largely housebound again. On that occasion, magnesium sulphate failed to pull me round – and I understand that subsequent trials of magnesium injections failed to replicate the success of that first study.

Nevertheless I am clear that magnesium injections helped me on that first occasion. I had several courses of six weekly injections. Each time, I began feeling better after the third week. The improvement would be sustained until a few weeks after the course but then tail off again. We eventually discovered that the best regime for me was an ongoing course of injections every three weeks. I kept this up for several years, stopping from time to time to see what would happen. Eventually I reached the stage where the injections didn’t seem to help any more. Why was this – and why did subsequent studies not replicate the success of the first?

A possible explanation might be found in the theory of mitochondrial dysfunction in ME/CFS proposed by Dr Sarah Myhill. According to her theory, our mitochondria are no longer able to supply sufficient amounts of the vital ‘body fuel’ ATP, the production of which is highly dependent on magnesium status. Years ago, extra magnesium was all I needed to bring about substantial improvement. But other substances, such as Co-Q10, vitamin B3 and acetyl carnitine, are also vital to the ATP cycle. If these are also deficient, magnesium supplementation alone will not make a difference. If this theory is correct, this must have been what happened to me as the years went by. I became not only short of magnesium but of other substances too. And of course as we know, this is a very complex condition, one which I suspect gets increasingly complex with time. The mitochondrial problem is only part of the picture for many people. I was just lucky that the magnesium was enough to work the magic for me on that first occasion. I think ‘magic’ is an appropriate word for how it felt to me. It was like being allowed back into life.

I gathered from Dr Moxon that some of his other patients also responded well to magnesium sulphate injections. Some of them even got back to work.

Dr Moxon had a special interest in ME, having known a fellow medical student who went down with glandular fever and never came back to the course. When he read the Lancet study, Dr Moxon saw an opportunity to help his ME patients and did not hesitate to take it. These days, there are very few doctors in the NHS who would do what he did. Dr Moxon is long gone unfortunately. I understand that his surgery still give magnesium sulphate injections to those who have been receiving them for many years – but they do not offer them to new patients. With only a single unreplicated study to support them, they are not in the NICE guidelines.

In the twenty-five years since I first received those injections, there has been a great change in the way that NHS doctors work. Medicine for them has become less of an art and more a set of tick-boxes. The all-powerful NICE guidelines were originally intended to be what they say they are: guidelines for doctors. In time, however, they seem to have come to be viewed as unbreakable rules, comprising between them the bible of evidence-based medicine. Doctors prescribe therapies which are not recommended by NICE at their peril. There are two reasons for this: fear of legal action if something goes wrong, and fear of unleashing the wrath of their local CCG (Clinical Commissioning Group) which guards its budget jealously and regards the NICE guidelines as an invaluable tool in the fight against what it sees as unnecessary expenditure.

One of my correspondents, Steve Hawkins, referred me to a document called ‘The Legal Implications of the NICE Guidelines’ which originally appeared on the NICE website but is apparently there no longer. It can however still be found on the Forward ME site, Steve having sent them a copy too. The document includes the following:

Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgment. However, NICE guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian/carer.

In particular, guidance that does not recommend a treatment or procedure, or that recommends its use only in defined circumstances, is not the same as a ban on that treatment or procedure being provided by the NHS. If, having considered the guidance, a health professional considers that the treatment or procedure would be the appropriate option in a given case, there is no legal bar on the professional recommending the treatment or on the NHS funding it.

This certainly gives the impression that flexibility is intended and that, in spite of the NICE guidance, doctors are still encouraged to exercise their clinical judgment.

It is not clear whether these legal guidelines are still current, yet the same attitude was still in evidence when Prof Mark Baker of NICE addressed the Forward ME Group at the House of Lords in June 2014. He said that the ME/CFS Guideline ‘did not meet (patients’) needs and did not meet NICE’s either… It did serve a purpose because it was the only bit of guidance in the NHS on ME/CFS, but it was limited in its scope. It was designed to get patients seen and helped, but it assumed there were specialists who knew what to do – and there were not… The Guideline was not comprehensive guidance and it did not promote innovation. It referred to only “passive” interventions such as CBT and Graded Exercise. There was not much of an evidence base to go on, and in NICE it was evidence that drove guidance.’

The impression given is that the guideline was intended as a bit of help for doctors but that they were also expected to use their own initiative, that specialists would ‘know what to do’, meaning – presumably – that they would be expected to use their skill and experience to help their patients. As Prof Baker admitted, however, this doesn’t seem to have happened very much, if at all.

Coming right up to date, a blog by NICE Director Prof David Haslam appeared on NICE’s site in recent days (11^th March). Dr Haslam wrote:

‘Although the guidance should be fully taken into account, the views of the person being cared for and a doctor’s or other professional’s experience can and should affect decisions about care.

‘The new text reflects NICE’s changed and broader work in social care and it explicitly flags the importance of the views of the patient or person receiving care. It should help clinicians to use NICE guidance with confidence – balancing their experience, the needs and wishes of the patient, and gold-standard evidence-based recommendations.’

The ‘new text’ referred to seems to be the newly issued guidance about the guidelines. I can’t find a direct link to this text but from the quote above there appears once again to be the intention that doctors should be able to use their own experience in deciding the course of treatment. Furthermore, the views of the patient are deemed to be important. Dr Haslam goes on to expand on this further:

‘70 years after the founding of the NHS, we are living in an age when people will increasingly take responsibility for their own health. This right is enshrined in the NHS Constitution. I believe this can only be good – the more people take control of their health, and the earlier they do it, the better it will be in the long run.

‘To do that, they have to be at the centre of decisions with expert judgment from health professionals and informed by expert guidance.

‘Decisions can be guided by bodies like NICE where evidence and expertise have dictated our work; but increasingly the old ways of prescriptive, top-down medicine are dead, as our new guidelines recognise. Now we have to bury them.’

Hmm. So ‘increasingly the old ways of prescriptive, top-down medicine are dead’. I’m not sure that is how it seems to patients at all. What is your experience?

It seems to me this is an excellent aspiration – and perhaps Dr Haslam is fully aware this is all it is. But if he really thinks that this way of doing things is ‘dead’, then it seems to me he is deluding himself. I think some, though by no means all, doctors are now happy to engage with patients in making decisions about their treatment. Some are even relaxed about patients who have researched their condition on the internet and have suggestions to make about what might be done. But the doctors themselves are not free to accommodate their patients even if they would like to, not if the treatments in question are outside the guidelines. The guidance on the legal implications of the guidelines (as quoted above) might say otherwise. NICE themselves might think otherwise. The original intention of the guidelines might be otherwise. But in reality, as things currently stand, the doctors’ hands are tied by the CCGs and by fear of litigation.

When Dr Haslam talks about people ‘taking responsibility for their own health’ and ‘being at the centre of decisions’, what precisely does he have in mind? Is he just talking about patients choosing to have fewer sticky buns and less alcohol? Or is he talking about giving real power to patients?

Nobody wants to see well meaning doctors in fear of litigation – they have enough stress in their jobs already – but would it truly be impossible to really empower patients by enabling them to request – and obtain – treatments which are outside the NICE guidelines? To allow patients real responsibility by signing disclaimers so that, after making sure they are fully informed of the facts, they shoulder the risks themselves?

Is this such an irresponsible suggestion?

In the case of ME, there are numerous treatments which are frequently reported to be of help but are not yet supported by sufficient evidence to be included in the guidelines. Magnesium sulphate injections are only one example. Others are Vitamin B12 injections, (LDN) low dose naltrexone, and (where there is appropriate evidence of viral activity) long-term antivirals such as acyclovir and valacyclovir.

Most of these are only available at present via private doctors, though B12 injections and acyclovir are prescribed at one of the NHS CFS/ME clinics. The best you are likely to get at the other such clinics is advice on illness management, which can be invaluable in itself yet is hardly enough. If you are unlucky enough to live in the wrong area, they will put you on a graded exercise programme instead. This is not patient power. It is post code lucky dip.

Of course the CCGs wouldn’t like it if the treatments I am suggesting could be prescribed – along with similar ones for other conditions. It would cut into their budgets. But would it really represent a financial loss to the country as a whole? The treatments I have mentioned are not particularly expensive and it seems likely to me that many patients would be enabled to get back to work. There might be a net saving for the country – and perhaps an even more substantial saving in the suffering of patients.

Of course, ideally we all want fully proven treatments, and there are signs that after many wasted decades, serious research into ME may finally be taking off. But proven treatments may still be a long way down the line. There is widespread understanding that the ME/CFS diagnosis may embrace more than one condition, perhaps even more than one neurological condition. There will certainly be sub-groups and it is unlikely that one treatment will work for everyone. It will take a while to see the wood from the trees.

I am over sixty now, so I don’t think it’s unduly pessimistic to say that I don’t know if there will be proven treatments in my lifetime. One thing I do know is that without those magnesium injections I would probably have been housebound the last twenty-five years. How much extra would that have cost the state, I wonder? How many more people could be helped today – and how much might be knocked off that growing disability bill which so troubles the government – if doctors’ hands were cut free from the ‘guidelines’ which have come to be seen as shackles – and their patients were truly empowered?

P.S.

1. A large part of the reason that the treatments I have mentioned have not been adequately researched is that they involve natural substances or old (generic) drugs so the financial incentive to make a lot of money for the drug companies isn’t there. Full marks then to the ME Association who have just announced funding to research the efficacy of Dr Sarah Myhill’s mitochondrial function test.
2. It is worth mentioning in passing that Dr Myhill’s model of mitochondrial function offers a viable explanation not only for post exertional malaise but also for the build up of lactic acid which has been observed in ME/CFS.
3. It is ‘interesting’ to compare the aspirations for patient empowerment set out in Dr Haslam’s NICE blog with the North Bristol NHS Trust advice on managing ‘chronic multiple symptoms’. As mentioned in an earlier post, this advice involves an exhortation to keep patients away from other doctors, to persuade them to ignore new symptoms, and to develop a ‘therapeutic alliance’ with a close relative to enforce the doctor’s perspective. It is difficult to imagine an approach which would be less empowering – yet this guidance is being openly shared on an NHS website.