Antibiotics for Back Pain – Break-through or False Dawn?

The headlines on back pain this week are hard to ignore. The Guardian, not known for its sensationalist health claims, chose:

Antibiotics could cure 40% of chronic back pain patients.

It’s enough to make a GP sit up and take notice – I can only imagine what I might think if I was living with pain that my doctors had long since given up on.

The newspapers have caught up on an article published in the European Spine Journal in February (funny how these things lie quietly in the medical literature and then all the papers find them at once!) The article was the findings of a Danish trial examining the use of antibiotics in the treatment of long-standing low back pain, and the results are certainly promising – with significant improvement in pain in the treatment group versus placebo. There is a good rationale behind why antibiotics might work, as well as MRI scan findings that should help in the selection of patients who could benefit. The study has been very well critiqued here by Neil O’Connell. I would recommend reading his paper, as I don’t think I can better his analysis.

The key question is what the medical establishment now does with the findings – we need to tread very carefully. At the moment this is the result of a single research group in a relatively small study. For all we know this may have been caused by a statistical blip, an unseen bias, or even scientific fraud (I have absolutely no reason to think it is fraud, but we should never be so naive as to not consider this as possible, until findings have been replicated elsewhere). The results certainly justify a large, multi-centre trial to fully evaluate the hypothesis.

The problem is that we already have the technology to evaluate back pain with an MRI scan, and the antibiotics are established and inexpensive drugs. The temptation for doctors to agree to treat their patients with antibiotics ‘to see if it works’ will be very great – especially for patients in whom nothing else is working. We must resist this, as there are two equal and opposite dangers if we do not.

The first is that this turns out to be an erroneous finding, and thousands of patients are unnecessarily investigated, treated and harmed before, years down the line, the hypothesis is finally refuted and practice reverts to normal. The history of medicine is littered with examples of this – from the horrors of frontal lobotomies in the 50’s, to unnecessary tonsillectomies in the 70’s, or the over-use of aspirin in primary prevention of heart disease and stroke as recently as the last decade. It can be quite a task to put the Pandora’s box of over-treatment back where it came from once it has been unleashed.

The second danger is that this really is a break-through. That it is the Helicobacter pylori moment in the treatment of back pain (Helicobacter is the bacterium responsible for the majority of stomach ulcers and its discovery and treatment has revolutionised the management of this condition). If this is so, then we need robust evidence to establish this new way of thinking so that the majority of people can benefit. If treatment starts to become commonplace without evidence then it could remain the territory of private clinics and maverick surgeons who are more focused on pleasing their patients than practicing robustly evidenced medicine. NICE may never approve it, or take several more years to do so than it should, and many patients may miss out in the long run.

So what to do if you have back pain? Well, for now it is best to watch this space with interest. We really do not know at this stage if you would benefit from antibiotics or not. If a clinical trial starts, seriously consider enrolling on it – so that you can play your part in answering what is clearly a pressing clinical question.

Whooping Cough Vaccination for Pregnant Women: Neat Idea, Missed Opportunity

New medical advice is transmitted at such lightning speed these days that GPs and their patients often have to work their way through it in tandem. This was illustrated to me quite starkly on Friday morning with the announcement of a new, temporary vaccination programme in the UK for pregnant women to protect their children from whopping cough. The first I heard about the proposal was on the radio over breakfast, by mid-morning I learnt that all GPs had been sent an e-mail with the new instructions, and before lunch I was trying my best to advise one of my pregnant patients on the issue. Funny how you can feel reasonably up-to-date on Thursday evening, and behind the times only 12 hours later!

Having had the luxury of the weekend to actually read the information from the Department of Health I feel a little more prepared to advise women in the coming week – and this is what is required of a GP these days. It is not sufficient simply to adhere to the Government line on these matters; patients expect, and deserve, a doctor who will consider medical advice carefully and be willing to give thoughtful guidance. And my conclusions? In a nutshell, it’s a great idea, but why, oh why, oh why are the Department of Health not conducting a proper clinical trial?

The proposal is to vaccinate all pregnant women between 28 and 38 weeks gestation against Pertussis (whooping cough) as a temporary programme in response to the significant rise in infection rates in the last 2 years. And whatever else we think, it is certainly a neat idea. We do have a problem with Pertussis at the moment, both in the UK and worldwide. The number of confirmed cases so far in the UK in 2012 is nearly 5000, compared with around 1000 for the whole of 2011. There is no doubt that this is in part due to greater awareness of Pertussis at the moment on the part of doctors (myself included) and so increased diagnosis of cases in adults that would previously have been missed. However, this seems to be more than just an artefact, since there has been a sharp rise in the number of cases in infants under the age of 3 months, many of whom become very unwell and in whom diagnosis will always have been much more accurate. It is the very young who are the concern with Pertussis, since they will not yet have immunity from the vaccination programme, and their small lungs are especially vulnerable. So far in 2012 there have been 9 deaths in babies in the UK, and many more will have been seriously unwell.

How best to protect these babies? Well if everyone was immunised then there would be no-one to transmit the infection to them (the protection afforded by herd immunity), but this is extremely difficult with Pertussis since the protection afforded by vaccination wanes within a few years. Unlike the recent measles epidemics where poor uptake of MMR is clearly to blame, most cases of Pertussis in older children and adults occur in people who have been fully vaccinated. A programme where everyone was immunised every 5-10 years would work, but the cost of this would be enormous.

The beauty of vaccinating pregnant women is that we know the woman will make antibodies against the disease, and that these can cross the placenta in late pregnancy, be taken up by the baby and could afford protection in those crucial early weeks until the childhood vaccinations have kicked in. A single vaccine therefore protects exactly the at risk individual, and there is no need to depend on herd immunity. When a mother chooses to accept the vaccine she is choosing to protect her own child – the personal potential benefit is very clear.

We have good reason to think the vaccine is safe. It is a killed vaccine, which means it cannot possibly cause active infection, and these vaccines have reliably been shown to be safe in pregnancy. The vaccine also contains diphtheria, Tetanus and Polio vaccination (there is no single Pertussis vaccine so the combination has to be used) and the first two of these have often been used in pregnant women without difficulty. While there is not much data for this exact vaccine it seems extremely unlikely that there are any risks other than local reactions in the arm and very rare allergic reactions, and only vaccine conspiracy theorists are likely to argue against this.

It is also likely to work. I agree with the conclusions of the expert committee that:

…it is reasonable to assume that this approach would provide young infants with some important, although possibly not complete, protection against pertussis, and it is likely to be the most effective immunisation strategy to provide protection to young infants.

The report also state, however, that

the effectiveness of prenatal immunisation against pertussis to protect young infants is uncertain.

There are reasons to think it might not work. Will the maternal antibodies be sufficient to truly protect? Is there any risk that the antibodies might actually interfere with the response to the infant vaccination programme, and lead to reduced immunity later in childhood? So what should a scientist do when he or she has a good hypothesis which is uncertain: Test the hypothesis with a trial. There is such an opportunity here to answer this question for both the current and future generations – we need to conduct a Government funded, blinded, randomised clinical trial. Instead of rolling out this temporary programme as a knee jerk reaction, pregnant women could be offered the chance to be in the trial. They would receive either the vaccine or a placebo injection, meaning adverse reactions in the pregnancy could be compared, as could infection rates and outcomes in the babies.

Within a year we would start to get a real answer to this question. If it works then this could become a permanent and valuable addition to our fight against this serious disease. If it is shown to be ineffective then we could stop wasting time and money, go back to the drawing board and look for a better solution. What is more, the vaccine itself would be protected against unfounded claims of harm. Sadly the background rate of stillbirth is sufficiently high so that the Daily Mail headline “Whooping Cough Vaccine Killed my Baby” might as well have already been written, and without the robust clinical evidence available from a randomised trial these inevitable anecdotal stories will be much harder to evaluate. Granted, the trial would need to be large and the cost would not be insignificant, but the long-term gain of truly knowing how to protect babies from this infection must surely be worth it.

So how should I advise my patients in the lack of proper trial data – well it is a shame we shall never know for sure, but the issue is important enough to take action, and the balance of risk has to be in favour of the vaccine.

The Binscombe Express rides again! The Triumph of Common Sense and the Power of Twitter

When the Infection Control lead for Surrey PCT advised me that the wooden train set in my consulting room would be deemed an unacceptable infection risk by the Care Quality Commission (CQC), I responded like most of us do when faced with a powerful figure in authority. That is to say: I muttered about it, sulked a bit, complained loudly to my family, and then assumed that nothing could be done. After a few days I thought I would write a blog on the subject – after all, then I could mutter, sulk and complain for a bit longer, and to a few more people – but I still assumed that nothing could be done, and duly complied with the order from above.

It was when I shared the blog on Twitter that things started to get interesting. It stimulated a moderate response at first, but an encouraging one. One or two people commented and added their complaint to mine, there was the odd retweet and I at least felt listened to. Then, on Sunday night I came across a tweet concerning a piece of research that demonstrated how unlikely it was to transmit infection via inanimate objects – like toilet seats and library books. Emboldened by the previous support I had received, and empowered by this piece of evidence, I posted a link to the blog again, and asked if anyone was aware of any research on the subject of toys in GP surgeries, stating that I might try to contest the instructions we had received.

They say that timing is vital on social media sites, and (by accident rather than design) the timing on this one was just right – it was about half an hour after Andy Murray’s heart-breaking defeat in the final of Wimbledon and the Twitter world, which had been in a peculiar slumber during four tense sets of tennis, had suddenly woken up. Maybe it was a lingering desire to support the cause of the under-dog, or perhaps the idea of bureaucrats taking a child’s toys away really struck a chord, but within minutes GPs and patients alike were tweeting and retweeting faster than I could keep up.

The cause came to the attention of Margaret McCartney, a GP in Glasgow who knows how to fight for a just cause (her blog is well worth a look, as is her book The Patient Paradox). She immediately involved the CQC in the conversation (I had not even thought they might be on Twitter!) and resolved to get a response from them the next day. Before I had finished my morning surgery there was a clear statement from the CQC (see comments on my previous blog) that they had no problem whatsoever with toys, wooden or otherwise, and that Infection Control teams were being over zealous in their advice. By mid-afternoon Surrey PCT had backed off somewhat, issuing a media statement to that effect, and I was being interviewed by The Telegraph!

I am delighted that Binscombe children will now be able to play trains in my room for years to come, and my faith has been restored in the CQC. I’m just as encouraged by the media attention this has received – there was an article in The Telegraph yesterday, the story was also picked up by the GP magazine Pulse, and the Radio 4 programme Inside Health.  When I talk to other GPs I find that many are under the same pressure from their Infection Control teams as I was, and we need to get the right message out there.

One of the remarkable features of Social Media is the way it connects people from different disciplines – like GPs, patients and health journalists – and gets them talking together. Even two years ago it was unfeasible that most ordinary GPs would communicate directly with health journalists, and now it can happen on an almost daily basis. Whatever else we think about this internet age there is no doubt that there has never been more opportunity for ordinary people to have an impact – whether it is a GP from Godalming scoring a minor success like this, or something more dramatic like a 14 year-old girl changing the editing policy of a major teen magazine, there is a vehicle for your voice to be heard if you have something interesting enough to say, and the passion to shout about it.

And as for the Binscombe Express? Well the discerning eye will have noticed from the photograph that it is in need of a little attention – sadly, the original 6 carriages I started with 10 years ago have dwindled down to only 3 – the result of some toddlers appreciating its appeal a little too much. Like any responsible Railway Proprietor, however, I intend to invest for the future and replace the missing carriages – well, at least I plan to raid the children’s old Brio set that’s stored away in the loft and see what I can find. Let’s hope they won’t notice!

The Binscombe Express – saved, and about to receive an uplift!

The Wrong Kind of Virus on the Line – the Demise of the Binscombe Express

I’m delighted to say that this post needs to be amended. As you will be able to see from the helpful comment from the CQC below, they do not have a problem with wooden toys. The advice we received from the Surrey PCT infection control lead that we had to remove wooden toys in order to be CQC compliant was misguided, and the Binscombe Express can stay! I will be blogging again soon on how this came about, and have left the blog in its original form below, but am very grateful for the swift clarification and common sense approach of the CQC.

Here is the original post:

This week saw the Binscombe Express roll out from the station for the final time, pushed reluctantly into an early and unwanted retirement. It might never have rivaled the glamour of the Great Western, or the notoriety of the Orient Express, but in certain circles among the toddlers of Godalming it has ranked right up there in importance with Thomas the Tank Engine. I’m talking, of course, about the Brio train set in my consulting room. Lovingly home-made in a simple figure of 8, it has been the undisputed domain of my younger patients f or the last ten years. A room otherwise associated with illness, strange metal implements and painful injections has been given a friendly, familiar face by its presence, and I am desperately sad to see it go.

And the cause of its demise? Not, for once, austerity and the bankers, or even Michael Gove declaring it to be too educationally liberal – it is the edict of the Care Quality Commission (CQC) that has banished my train set, declaring it to be too hygienically hazardous to be allowed to stay.

The Binscombe Express – condemned by the CQC

The CQC has turned its attention on GP practices this year, with the intention to improve health and safety, and in particular, infection control. This is not a bad thing – to have rigorous procedures for the sterilisation of invasive medical instruments, for instance, is clearly a very good thing indeed; nor should GP practices aim for anything other than a high standard of cleanliness, but is a wooden train set really that hazardous?

The CQC website states that the guidance it applies is based on the Health and Social Care Act 2008, which has a great deal to say about infection control, but does not actually mention toys in GP surgeries. Despite this, it has become de rigeur for infection control teams to target these hazardous objects in our rooms, and in particular to condemn wooden toys. I have not been told what evidence this is based upon although I suspect it is on the basis of swab results growing numerous bacteria on their surfaces, which is odd as the vast majority of infections that children might pass to one another via my Brio would be viruses. Plastic toys are deemed acceptable as long as they are swabbed with an alcowipe at the end of the day – which is also odd since viruses won’t survive the night outside of their host.

I have no doubt that some parents will be glad to see the train go, and I am sorry for any concern it might have caused, but it is important to remember that this is not a long-stay hospital ward where people with poor immune systems and open wounds run the gauntlet of super-bug infection, but a GP surgery where children bring the same germs that they merrily carry with them to schools, playgroups and nurseries. And without the child-friendly toys in my room, it would be naive to think that children won’t try to play with something – the options they are likely to head towards now will be the clinical waste bin, the hydraulic mechanism of my examination couch, or the old favourite of opening and closing various finger-trapping drawers. Is this an improvement?

What concerns me most about this dictat from the CQC is the way it focuses on the potential health risks associated with toys, but is entirely blind to any health benefits. What value should we place on a child being at ease when they visit the doctor? Many adults are fearful of seeing their GP, and I suspect that much of this stems from negative childhood experiences which set a lifelong pattern of health-seeking behaviour. Can a train set make the difference? Well, I can’t answer that, but I have seen the eyes of many anxious children light up when they come into my room. And for more immediate benefits you would just have to compare the quality of the conversation between adults when a child is happily and safely occupied than when they are bored, fearful or frustrated – it is hard enough to remember what the doctor has said at the best of times.

There is a worrying underlying trend here which pervades so many Government directives these days – which is where that which is easily measurable and defined trumps that which is less easy to describe, regardless of any relative merit. We see this in education, where SATS scores dominate how both teachers and schools are judged, and no value is placed on a teachers’ ability to inspire and develop their pupils outside the narrow viewfinder of the test. The obvious example in health is the Quality and Outcomes Framework of the GP contract, which is based entirely on what can be measured – like targets for blood pressure, cholesterol and diabetes control. These are not unimportant, but the end result is that the humanity of General Practice, like deep listening, counselling skills and patient-centred care (which cannot be measured so easily) is in danger of being squeezed out of the consultation entirely.

There seem to be no grounds for appeal to reprieve my train set, but I will continue to resist any pressure that threatens to reduce the relationship between doctor and patient to mere figures and targets, and every so often I will continue to stand up and say: “Now, hold on a moment!”