Posted by: Janna Lawrence13 MAR 2013
Squashed in amongst men and women in black tie and evening gowns I eagerly await the evening’s entertainment. I am currently peering down from my velvet seat in the amphitheatre and curiously sizing up the two men who will step into the spotlight.
They are about to take part in a very public battle and I, with the rest of the audience, will decide who has won or lost. But this is verbal combat. Nonetheless, a volatile subject is to be broached: is the pharmaceutical industry getting its act together?
The head to head debate, organised by PharmaTimes, is taking place in the gloriously antiquated Royal Institution (26 February).
Taking to the stage are Ben Goldacre, of Bad Pharma fame, and Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry (ABPI). Both have publicly aired their dislike of the other’s opinion on this matter but are keen to exchange somewhat barbed compliments.
Dr Goldacre and team, including BMJ editor, Fiona Godlee, urge transparency of clinical trial data and have been spurred on recently by the success of the “juggernaut” that is the All Trials campaign. Dr Goldacre says that the dissemination of clinical research is fundamentally flawed. He cites evidence that overall only 50 per cent of clinical trials of medicines currently in use have been published.
Furthermore, the chance of a positive trial being published is double. In addition, he says, the industry continues to fail to comply with clinical trial registration guidelines and only 22 per cent of trials have been published on Clinicaltrials.gov within a year of completion, as recommended. It is noted that academia is a worse offender than industry.
But this is not simply a question of right and wrong, winner and loser; evil pharma against noble clinician and innocent patient. It is a far more complex and subtly hued debate.
Stephen Whitehead, quite dogmatically, says that the ABPI would not respond to PR-driven campaigns like All Trials. But I feel he is missing a PR trick if he doesn’t. The pharmaceutical industry has been responsible for a lot of good in the world, as he rightly points out, but public perception does not seem to reflect this. Signing up to the campaign would cast them in a better light.
Yet I think the point he is trying to make is that the All Trials campaign does not offer any practical solutions. It wants all clinical trials to be registered and all methods and results reported and it rallies to “call on governments, regulators and research bodies to implement measures to achieve this”. Which is great, really, a wonderful idea. But wait… any advice on those pesky measures that we should be implementing?
The crux of Stephen Whitehead’s argument seems to centre on this point. Although he agrees that full data transparency is a good thing, he argues that the ABPI and others are trying to achieve this — it’s just a much bumpier road than anticipated.
The devil is in the detail, as one of his supporters points out. Nevertheless, the ABPI has this month taken visible steps to try to encourage data transparency in line with its code of practice.
So all information should be available to researchers and the public — but this requires much more than social network campaigning to get these huge corporations to comply. A structured and thorough regulatory process needs to be put in place. I’d like to see Goldacre and co. put forward a range of solutions for scrutiny.
I agree that pharma needs to be brought into line, but someone needs to show them the way. Namely an organisation that can grab them by the bottom line. One that can impose fines or, even, carry out audits and inspections if companies fail to adhere to rules on clinical trials.
Of course pharmaceutical companies are unlikely to come forward with all their data voluntarily, especially when doing so might more than highlight their shortcomings.
I do believe public pressure is part of addressing the problem. Pointing the finger at those naughty pharma companies is all very well, but real and practical solutions are what is needed.