Open access to data in clinical medicine

A follow on from my last blog post about Multiple Sclerosis.

Yesterday, I was reading this post on Martin Fenner's blog Gobbledygook and left a short comment containing a link to a comment I had posted last year at PLoS Clinical Trials.

My comment over at PLoS was directly in relation to Liz Wager's 2006 Manuscript entitled Publishing Clinical Trial Results: The Future Beckons

When I re-read my PLoS comment, I wanted to spin back to this section:-

A few months ago (27th April), the BBC aired a real eye opener in the form of This World documentary "Drug trials outsourced to India". This can easily be found searching for "this world drug trials India". Even more recently, it was the BBC (again) who highlighted serious concerns about a MS trial "Concern over major MS drug trial". This can easily be found searching for "concern over major MS drug trial". Despite all of these issues, no-one seems to be concerned, and more worryingly, willing to do anything about this !!

I was alluding to two particular BBC documentaries about clinical trials.

When I originally submitted my comment to PLoS back in 2006, it wasn't possible to embed links.

The links are Drug trials outsourced to India and Concern over major MS drug trial

I repeat what I said, "Despite all of these issues, no-one seems to be concerned, and more worryingly, willing to do anything about this !!"

Now, let's spin back to Martin's post above:-

"This required reporting of results has so far largely gone unnoticed in the medical community, but will dramatically change the way research involving patients is conducted and reported. The 12 month deadline will probably lead to earlier reporting of many trial results, and not publishing negative results will be much more difficult. The required reporting in a standardized format will also facilitate the meta-analysis of several similar trials."

Now specifically in terms of Multiple Sclerosis (MS), to demonstrate the importance of what Martin is talking about, let's focus on that BBC report Concern over major MS drug trial

When I initially read it, I was quite literally stunned. So much so that it directly led to me writing to PLoS about my views.

As the BBC report says:-

"It is feared patients currently taking expensive drugs like beta interferon may be kept in the dark even after the ten year study is complete."

It appears that due to Pharma pressure, after 10 years research at a cost of £500,000,000 to UK taxpayers, all of this ultimately led to nothing.

Since I know him, I contacted Sir Iain Chalmers who aired his concerns to the BBC. In response, he said, "There’s a very nasty smell coming from the whole business, Graham."

As Martin flags up in the comments section of his post, and as I was already aware since I participated, the WHO recently carried out a Public Consultation entitled Reporting of Findings of Clinical Trials.

As such, taking all of this into consideration, the MANDATORY registration of data acquired from clinical trials to be made open is a very large step in the right direction. Moreover, with all of the mandates now bounding around for public access to such data/knowledge it certainly looks like, at last, we're moving out of the dark ages. About time too.

BBC Scotland Investigates: 2008: Scotland's Hidden Epidemic: The Truth About Multiple Sclerosis

PRELUDE

A major donation from Harry Potter author JK Rowling will help combat Multiple Sclerosis (MS), a disease which affects one in 500 Scots. Funding for the £2.5m project will largely come from Multiple Sclerosis Society Scotland, which has been gifted a substantial sum from the author for this work.

Yesterday, my Mum mentioned a documentary on the BBC that she saw the other day that I missed.

Being a UK TV License Fee payer, I was able to watch it online here via the BBCi-player.

If you are able to access it, I urge you to watch this most compelling 30 minute programme.

Living life with multiple sclerosis by Elizabeth Quigley, BBC Scotland

Whilst I never met her, my Mum’s mum died at an early age due to MS. The documentary was therefore of particular interest to us and I would suspect, the ~ 10,500 MS patients in Scotland and beyond.

The documentary features an interview with author, JK Rowling. JKR apparently rarely speaks about the loss of her own mother at an early age (45) to MS but chose to do so here and also here.

Further reading:-

Research features in TV documentary
JK Rowling and the Multiple Sclerosis Society Scotland fund a new MS Research Centre
Sunday Herald article