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.

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.