Editorial Note: This post is by Leonie Fennel. It’s one of two involving Leonie.
Last week, Dr Ben Goldacre gave a public lecture in the Royal College of Surgeons in Dublin (organised by the 3U Partnership and the very lovely Dr Ruth Davis). Dr Goldacre is a doctor, academic, campaigner and writer; he is also a psychiatrist and self-professed nerd. I was eager to hear what he had to say, not least as the subject-matter was ‘Bad Trials’ – so off I toddled to Stephen’s Green with a friend in tow, a psychotherapist. He, like me, has a personal interest – he has witnessed first-hand the devastation that can be caused by nothing more than a GP’s farraginous prescribing. He is also a very kind, funny, charming companion, so I was delighted to have any excuse to meet up with him. I’d also say he’s a handsome chap but the husband I abandoned for the day wouldn’t be too impressed.
Having read Goldacre’s ‘Bad Pharma’ book, we were both curious to hear what he had to say. Incidentally, he once called my English friend Fid a ‘Smeary Conspiracy Theorist’ – so apart from guaranteed entertainment, I wasn’t too sure what else to expect. In fact, his talk was fast-paced and as excitable as he is – he hops around like a Duracell bunny on speed and lets out intermittent roars, which effectively kick-starts the heartbeats of anyone not paying attention. Nevertheless, he attempts to make data and statistics fun, a nigh-on impossible task.
Needless to say, as the subject concerned ‘bad-trials’, he specifically mentioned GlaxoSmithKline’s notorious Study 329, although bizarrely managed to do so without mention of GSK (usually both are referenced synonymously). He seemed like an amicable chap and was quite happy to answer questions afterwards in the Q & A session.
I was interested to explore his views on Study 329 and asked his opinion on why the BMJ took a year (of much wrangling) to publish Le Noury et al’s reanalysis of it – and did he think it had anything to do with the BMJ’s clinical editor being married to a partner in Ropes and Gray, the same law-firm hired by GSK to defend the action brought by the US Dept. of Justice, where Study 329 was a central element.
Goldacre said that he didn’t know and didn’t care – that fraud and Conflicts of Interest were not of interest to him. He asked what the fixation with Study 329 was, as it was just one of the many trials where data was misrepresented?
He expressed the opinion that everyone knew from early on that the original study 329 was flawed and nobody really relied on it. I sincerely doubt that the authors would agree with him on that, but he is entitled to his opinion. The oddity as the photo shows he was talking about outcome switching which is what happened in this originally well-designed trial.
He went on to say that the reanalysis (Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence) was nothing new. It only did what had largely been done before and confirmed what everyone actually already knew.
Expressing my concerns that Study 329 was still not retracted, he asked what I wanted to happen, that all papers that are re-analysed and found wanting, be retracted? Erm, yes!
My friend, the dishy therapist, then said that wasn’t the crucial point being that 329 harmed so many children? Ben said once people have informed consent, they can make their own choices – like this is a common practice. He pushed Ben on the now-common practice of problematizing distress, with Ben suggesting that people need to be careful not to push their own biases onto others.
It struck me as odd that BG seemed disturbed by the discussion turning to study 329 – yet he had specifically brought it up himself. I thought it even odder that he didn’t give the re-analysis by Le Noury et al any credit at all. I got the distinct impression that while his forte may be in data and stats, the enormous numbers harmed by these fraudulent trials were given little consideration.
How can anyone say that people can make an autonomous choice to take a drug, when the (usually ghost-written) studies are manipulated to give positive results, while hiding serious harms?
The mammoth undertaking by Le Noury et al deserves huge recognition for exposing just this – that truly informed consent is impossible unless the full facts are provided.
Editor’s Note: Ben Goldacre has taken exception to this characterization. He comments below. His tweets on the issue can be found BG tweets