We Need to Talk About Conflicts of Interest

When I penned my previous post on the possible role of antibiotics in the treatment of back pain, I was unaware of one vital piece of information which, for me, changes everything: The doctors behind the research had a significant conflict of interest, which they had not declared when they submitted the article for publication.

This was first brought to my attention by Ben Riley, who keeps the Ferret Fancier blog, and the issue has also been covered by Margaret McCartney in the British Medical Journal. To summarise, three of the four authors are part of an organisation called MAST Medical, which states:

The latest research shows that back pain from Modic changes can be successfully treated with a prolonged course of antibiotic treatment.

To ensure that treatment is successful patients should consult a MAST certified doctor and/or therapist.

It is no surprise that to become ‘MAST certified’ requires attendance on a course run by MAST Medical, and payment of an inevitable fee. Apparently the authors did not think that this was a conflict of interest, because the website was launched three months after the article was published – a defence of their position which stretches the concept of conflicts of interest beyond breaking point.

The current system with regards to competing interests relies on self-declaration – this is a problem, since the editor of a journal cannot police every article that is submitted to them, or challenge authors concerning conflicts about which they are unaware.

Scientific method should make self-declaration a reliable system. A true scientist is more concerned about elucidating the truth than promoting their own interests; they will always be keen to see if their results can be reproduced by other researchers before declaring them to be proven; a true scientist may still have a conflict of interest – but they will positively want to declare it as they know that it could bias their interpretation.

Unfortunately, not everyone in the medical world behaves as a true scientist. This group, far from being concerned that they could be biased, have chosen to defend what is an obvious financial interest in the results of their trial. A cynic might guess that they delayed the launch of their website precisely so that they could get away without declaring it. As a medic I am very concerned that they are promoting antibiotics for the treatment of back pain before their results have been replicated elsewhere.

Sometimes declarations may fail to be made for very obvious reasons of personal gain – we only need to remember Andrew Wakefield and the MMR scandal to realise just how serious this can be – while at other times it may be due to laziness or thoughtlessness on behalf of the authors. An example of this more innocuous, but nevertheless important, neglect to make a proper declaration occurred when I wrote to the British Medical Journal, as part of a diverse group of people involved in healthcare, to raise concerns about the prospect of screening for dementia.

Our letter was initially published as a rapid response, where it triggered a reply from an eminent group of doctors who declared that they had no competing interests. The letter was subsequently published as an Observation article, and a further reply came from many of the same authors, several of whom decided on this occasion to declare interests, including financial support from pharmaceutical companies and appointments related to the field of dementia. These conflicts are not wrong in themselves, and do not invalidate their comments, but neither are they unimportant, nor did they arise in the intervening three-month period between the letters. What changed? A prick of the conscience? A word from the editor? Or perhaps the fact that the BMJ tightened its wording about conflicts of interests in January 2013 – between the two submissions.

Even a robust policy on this matter is insufficient, however. The BMJ has very clear guidance on what should be declared, but there is very little the editors can do when proper declarations are not made – with retraction of the article being their most draconian punishment. Retraction may have repercussions in the scientific community, but it is rarely reported on in mainstream media. The furore and excitement on the front pages of our national newspapers that surrounded the news that back pain could be treated with antibiotics is hardly likely to be repeated were the paper to be retracted by the journal at a later date, and so patients with back pain – and even their GPs – may never get to hear the full story.

The BMJ, along with many other leading journals, has encouraged the use of a uniform reporting system for competing interests, but this is by no means universal, and still lacks teeth. There needs to be a national debate on this important issue, and serious consequences for failing to declare significant competing interests. I don’t know what these should be – a ban on publication for a period of time, rather like a football player being suspended? A published apology? Even fines?

If this seems heavy-handed then we should remind ourselves of the consequences of misleading reasearch. Andrew Wakefield published his discredited research in The Lancet in 1998. It took 6 years before his financial conflicts of interests were unearthed by Brian Deer of The Sunday Times, but it was only in 2010, when he was struck off the medical register by the GMC, that the journal finally retracted the article. How much damage was done in the field of public health in the meantime – and is still being felt today as the outbreak of measles in Swansea is a stark reminder?

The danger with Wakefield is that we write him off as a dishonest maverick and fail to learn the lessons of a system that is broken and in need of a major rethink. We don’t need to wait for the next scandal before we talk about conflicts of interest – we need to do it now.

Measles – Ignorance and Complacency are the Greatest Dangers

Listening to the news reports surrounding the current measles epidemic in South Wales this week, it has struck me afresh how much our nation is in need of a refresher course on the nature of this age-old infection. While it has been one of the resounding successes of modern medicine that this potentially devastating disease is so rare in the developed world in the 21st century, this inevitably means that we have lost a great deal of the collective knowledge and understanding that was such a valuable resource when measles was commonplace. The contrast with chicken pox is clear – we still know this illness and understand it. Parents usually diagnose it themselves and manage it without needing any medical advice, only turning to a doctor when there seem to be problems. For measles, most of us know it involves a fever and a rash, and can be serious, but not much more.

The result of this is that we are left collectively stunned by the death of a man of 25 with measles. How can that happen? Isn’t a young man of that age supposed to be in the prime of his life, having escaped the frailties of childhood but well before the vulnerability of old age? And yet the risk of death as a complication from measles in this age group is the same as that for the under 5’s. In fact the age group that is most at risk of the major complication of measles – death, encephalitis (infection of the brain), hospitalisation and pneumonia – are the over 30’s. Young children are more at risk only for diarrhoea and ear infections.

It is no surprise, therefore, that a woman being interviewed on the radio recently had made the assumption that measles was only really a problem for the under 5’s. Why would she think differently? This is the case for other infections, after all. Whooping cough, for instance, will give you a nasty cough for 3 months as an adult, but it is infants whose life could be in danger. Haemophilus B, part of the vaccination programme for babies, can cause meningitis in the under 2’s, but not in older children. Yet if we assume measles is not a problem for older children and adults, then the greatest risk to a successful catch-up programme for the MMR vaccine is not those ideologically opposed to vaccination, but ignorance and complacency among those with a more moderate view, but who were caught up in the confusion surrounding MMR in the late 1990’s.

It is easy to see why measles is so associated with childhood in our collective unconscious. The disease is so infectious that, before vaccination, it was rare to get to the age of 5 without having succumbed to it – and so our image of the infected patient is usually one of a child. The vaccination programme is delivered in two doses, at around 1 year of age and again pre-school – so we have no reason to associate it with any other age range. The fact that 10-18 year-olds are the primary age group affected by the outbreak in Wales, however, is a stark reminder of the naivety of these assumptions, as it is clear that this infection is no respecter of age, and anyone who lacks immunity is vulnerable.

The post-mortem of the young man who died has been described as inconclusive – there is no doubt that he had measles, but at the moment it cannot be said with certainty that this was the cause of his death. Well, it seems to me that it stretches to incredulity the idea that someone who dies with measles has not died from measles. I suspect we are making another false assumption about his death, however. The fact that he was found dead in his flat could easily make us draw the conclusion that if only he had sought medical advice, he might still be alive now. In truth it is unlikely that a hospital would have been able to do anything. We have better supportive measures these days than in the past, but there is still no treatment at all for measles encephalitis – it always has been, and remains, a lottery – the risks are low (1 in 1000 cases overall, 3 in 1000 for the over 30’s), but the stakes are devastatingly high.

Public Health England are absolutely right to launch a vaccination catch-up campaign across the country rather than just in South Wales. It would be tragic indeed if we waited for an epidemic to break out locally before anything was done, and there are many areas in the country where the drama of what has happened in Swansea could be re-enacted at any time. There is no reason to wait to hear from someone about this either – if you or your child are not fully protected (by either a clear history of having had measles, or two MMR vaccinations) then you can go to your GP this week and ask to be vaccinated. There is no upper age limit. There is also the interesting phenomenon that the children who may have missed out on MMR when they were younger are getting to an age where they can, and should, express their own views and may wish to contact their GP for advice themselves.

A final word about the situation for younger babies, which is a little more complicated. Under 6 months the MMR vaccine is not licensed, and should not be given. These babies also have a great deal of residual immunity from their mothers and so are not at great risk. Over 6 months the vaccine could be given if there was felt to be a significant risk – for instance if someone was planning to visit South Wales. This would be based on parental preference, and is not a clear recommendation. The problem with vaccinating earlier than the usual schedule is that the maternal immunity can neutralise the effects of the vaccine, and so any MMR given early does not ‘count’ towards the schedule and 2 further doses will still be required. For the most part it is best to wait and undergo the usual vaccination programme schedule.

MMR – it really is never too late

Baby clinics in the late 1990’s were a challenge for all involved. The baby check itself was fine – a well, happy baby is often light relief at the end of a busy morning surgery – but the discussion over MMR was never easy. Taking as long as the rest of the baby check put together, it was heart-breaking to see parents attacked by the twin spectres of measles and all it’s potentially devastating consequences on the one side, and the equally worrying and poorly understood condition of autism on the other. Parents were left in the unenviable position of feeling that whatever decision they made they were taking a risk with their child’s health.

As the story developed over the coming years, and the alleged association between MMR and autism was discredited, there was an almost palpable relief when I spoke to parents, as we mutually acknowledged that we didn’t have to go there anymore and could concentrate on the real worry that any parent has when they bring their child for vaccinations – how to look after them through an injection!

The MMR scare has left it’s legacy, though, and we were reminded of this in the news this morning. There has been an increase in the number of measles cases in the UK – numbering around 300 so far this year, which is as many as for the whole of last year. Parts of Europe have been worse hit, with several thousand cases in France, including incidences of measles encephalitis, where the brain itself is infected by the virus which can lead to death or brain damage. There are still many children in the UK who missed their MMR in the 1990’s and early 21st century and remain at risk. These children are fast approaching adulthood, and I worry about Rubella as the age of child-bearing comes near.

Many parents might now feel comfortable about catching up on the MMR vaccination, now the scare is over and their child is that much older. It really is never too late to have the MMR vaccine – there’s no upper age limit and it is always worth catching up. For patients at Binscombe, simply make an appointment to see the nurse if you or your child have not received two doses of MMR, and we can sort this out for you. If you are not sure what vaccinations you have received, we can easily check your record and let you know.