Strategic MedComms Forum 2011 part 2: guidelines and transparency

This is the second in a 2-part blog post. If you missed part 1, you can read it here.

So, on to the 3rd session of the day, “Good Practice Guidelines. A Triumph of Hope over Experience?”, which was led by Charlie Buckwell from Complete Medical Group. There are many guidelines which define good practice in pharma industry publications (which for the most part are remarkably consistent with each other), and yet there is still a widespread perception that pharma industry publications are thoroughly evil. Charlie showed us a YouTube clip which gave a good idea of how some journalists, either because they are seriously uninformed or because they think conspiracy theories always sell, continue to tell untruths about how the pharma publishes its research.

Nonetheless, although that YouTube clip is an extreme example of uninformed nonsense, it is still a fact that bad behaviour by the industry in the past has left a lasting reputation of shady dealings. So a question asked by this session was whether there is still a gap between the ideal, as defined in guidelines, and the reality of how we are publishing our data. The honest answer to that is that we don’t really know, as there is a lack of data. Charlie did point to my own data which shows that ghostwriting is becoming less common, although we still don’t really know how common it is.

Many people in the room said that they always advised clients on good practice and would turn down work from a client who wanted to work in an unethical way, and I have no doubt that that is true. What worries, me, however, is that the audience consisted of people who are highly engaged the mainstream medical communications community and are up to speed with current ethical standards, whereas there are no doubt other people working at the fringes of the industry who take such things less seriously. Are there many companies out there working unethically? And if there are, how do we reach them and encourage them to work more ethically? I don’t know the answers, but as I mentioned during the session and have argued elsewhere, I really think that medical journals could do more to enforce ethical publication standards.

The final session was called “Does Transparency Lead to Trust? Or Just Loss of Control?”, and we were fortunate to have Dr Ben Goldacre on the panel. Ben comes at the issues around publishing clinical trials from a very different perspective to most people in the room, and is not afraid to challenge other people’s opinions. That’s a thoroughly good thing, as it guards against sliding into lazy groupthink. Having said that, I was convinced that we are all on the same side. We all want to see clinical trial results published in full and in a transparent and ethical manner.

However, we didn’t seem to be agreed about how much progress had been made. Most people in the room believed that, although we have probably still not reached the ideal of publishing all our trials in a fully transparent manner, we have made huge progress towards it in recent years and that the trend is moving inexorably in the right direction. That’s a view I hold myself, partly reassured by recent research showing that, although the pharma industry can be slow to publish results, it does eventually publish results more completely than non-industry researchers do.

Ben, on the other hand, did not agree. He started off by telling us the story of reboxetine, in which 74% of the data (most of which was negative) had not been published. This was a clear case of unacceptable publication bias, but largely involving trials done in the 1990s, when standards of completeness of publication were different to how they are now. I find it hard to believe that a similar situation could occur now, but Ben told us he didn’t believe anything had really changed. He used the phrase “transparency theatre”, to describe the pharma industry putting on an outward show of being transparent, while continuing to hide unfavourable data in reality.

This isn’t a description I recognise from working with our clients, who are mostly keen to ensure they are complying with legal requirements to post study results on the clinicaltrials.gov website within the 12 month time limit, and many other comments from the assembled delegates expressed similar surprise. However, Ben described a piece of research that he has done recently, but not yet published, which he claims shows that only 20% of pharma-sponsored clinical trials comply with the requirement to post results within 12 months of study completion. Without seeing that publication, it’s impossible to comment further on those results, but I look forward to seeing them when they’re published.

Despite some disagreements and some reason to think that there may still be serious problems with the way pharma publishes its trials, I thought the day ended on a very optimistic note. There was a real feeling of momentum towards striving for ever greater transparency and high ethical standards. I and many of the others in the room (including, wonderfully, both Ben Goldacre and Phil Hammond) have agreed to continue working towards these goals. Exactly what form that work will take will no doubt have to be thrashed out over the next few weeks and months, but I suspect it will have to focus first on identifying exactly where the main problems still exist, and then how we are going to solve them.

I am looking forward to being a part of those activities. Watch this space. And, as ever, if you have any thoughts on how we can improve transparency in clinical trials publications, do feel free to add your thoughts via the comments box below.