I haven’t Been Paid to Write This

There were two items in the news last week that created an interesting juxtaposition on the issue of transparency.

The first concerned the new guidelines for Vloggers – those entrepreneurial YouTubers who have managed to create a following by recording short video clips of their lives, hoping to earn a few pounds along the way.

Some, it seems, have been earning extra money by being paid to recommend products to their viewers – Oreo biscuits being the most high profile example – and such is their influence that new rules have been established to make sure the unsuspecting public know money has changed hands. In short, they can recommend anything they like, but must make a clear declaration if they’ve been paid to do so.

The BBC news cheerfully put together item where three young female Vloggers dutifully explained the new rules, gaining some useful exposure for their own YouTube channel along the way.

You can hardly object to the rules; transparency is important and the consuming public should not be misled.  These young women hardly seemed to be a major threat to society, though, and you couldn’t help thinking that the establishment had come down hard on some enterprising young people who had found a way to start saving for a mortgage.

The second item concerned e cigarettes. Public Health England had produced a report stating that e cigarettes are ‘95% less harmful’ than standard cigarettes and suggesting that they should be prescribed on the NHS in the future.

The report is not a new study, but the opinion of a group of experts who have looked at all the evidence that is out there and given us the benefit of their combined wisdom.

Now, when a Vlogger declares one brand of biscuit to be superior to another, we have a right to know whether or not they have any financial incentive to say so; as Shahriar Coupal, director of the Committee of Advertising Practice says: ‘it’s simply not fair if we’re being advertised to and are not made aware of that fact.’

So what if a scientific expert declares one type of cigarette to be safer than another? Do we not have the same right to know whether the expert has had any financial dealings with the makers of cigarettes? Good medical practice would certainly say so, but the practical reality is often very different.

I have looked at the report in detail. The names of the authors are clear, but nowhere in its 111 pages can I find any declaration of interests; I have no way of knowing whether or not these authors have been paid by the makers of e cigarettes.

Which is more important? The type of biscuit someone may buy after watching a video on YouTube, or the health advice given to the nation by Public Health England on something as topical as e cigarettes?

I’m not stating that the authors do have any conflict of interests – they may well be entirely free from such ties – but the issue is that I cannot tell. If they have no such links, then tell me – I will be far more willing to trust the opinion of these experts if that is the case. If, on the other hand, they have received money from industry, then I have both a right and a need to know – for the sake of my patients and the advice I may pass on to them.

The authors may have made declarations of interests elsewhere, but this is no good to me since I don’t know where to look, and anyway, why should I be required to hunt for them? The Vloggers have to make a declaration on the page where they advertise the product, it should be no different for Public Health England.

Why are these declarations so often absent in reports like this? Is it thoughtlessness, laziness, or something more sinister? I don’t know, but it should be different. We need a culture change until it becomes unthinkable to publish such a report without them. We need a media that will focus the story on the lack of such a declaration rather than on the report itself – which is, after all, meaningless without it.

So what do I think of the report itself? Sadly, until I know if I can trust its authors I just don’t think I can make a judgement.

Addendum

As you will be able to see from the comments below, Public Health England have amended the report to include full DOI on pages 90 and 91 which is great news!

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.