GSK have promised to share all trial data: should we trust them?

October 11th, 2012 by Ben Goldacre in big pharma | 1 Comment »

Briefly: today, several people have asked for my response to this story in the Guardian, celebrating GSK’s promise for more transparency on their trial data.It is always good to hear a drug company making promises, and I hope that GSK will stick by the commitments they have made today.

But we should judge drug companies by their actions, not by their promises, especially when similar promises have been made in the past, and then broken.

In 1998 GlaxoWellcome promised to set up a clinical trials register, amidst outcry over withheld trial results. But when the company merged with SKB to create GSK, in 2002, this register was unceremonially deleted from the internet. This tragic story is described in an excellent open access article on this history of attempts to get access to hidden data, by Iain Chalmers.

Then, in 2003, GSK were caught withholding clinical trial data showing that their drug seroxat increases the risk of suicide in young people. As part of the settlement on fraud charges, in the US in 2004, GSK were forced to promise to post all trial results on a public website. But in 2012 GSK paid a new $3bn fine for criminal and civil fraud: this included charges over withholding data on the diabetes drug Avandia, as late as 2007, well after this earlier promise of transparency was made.

This pattern of broken promises around clinical trial transparency extends throughout the industry, and beyond. In 2005 the International Committee of Medical Journal Editors made a promise that they would only publish trials that had been publicly registered; but in 2009 it was found that they had routinely broken this promise.In 2007 the FDA Amendment Act promised that all trial results would be posted online at within a year; but in 2012 it was shown that only one in five trials had met this commitment. This is an ongoing scandal, harming patients, but incredibly, the ABPI – the UK pharmaceutical industry lobby – simply denies that the problem exists.

I think Andrew Witty, the current head of GSK, is a good guy, and I discuss this at length in the afterword of Bad Pharma: because I don’t realistically think that we can rely on one person in one company being nice, as a strategy to address ongoing regulatory failure in a global $600bn industry where lives are at stake. So it is great that GSK has made further promises of greater transparency, but promises are not enough, because they have been broken in the past. We will only see if this promise is different, in the decade to come.

It’s worth noting, by the way, that the US coverage of this GSK initiative was far more cautious, documented the problems with GSK’s behaviour in the past, and explained far more clearly that this is not about sharing the results of trials, but rather about sharing more detailed data from trials to help spot interesting patterns. It’s a great initiative: I call for it in the book, I hope it happens at GSK, consistently, and I hope it is copied. But this one initiative does not address the ongoing problem of missing trial results throughout medicine, or the ongoing failure of the medical bodies, patient associations, ethics committees and universities to address this ongoing threat to patient care. And it doesn’t address the fact that there is no competent and enforced legislation to prevent companies from hiding data.

US coverage:

(Oh, and footnote: Patrick Vallance, GSK’s current supreme medical person? If you were at UCL medical school doing your clinical training, in the late 90s, like me, then he was the clinical pharmacology prof who taught us how to prescribe. Nice guy, smart guy.)

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One Response

  1. heavens said,

    November 6, 2012 at 12:39 am

    You know, there’s probably a provision in US law, whereby someone can sue the agency responsible for levying those US$10K/day fines over their failure to do so.

    If I were a pharma company, I’d first make sure that all my trials met the letter of the law (if not its spirit), and then see about suing over my competitor’s failures. US$3.65M/year might not be very much, but if you multiply it by a hundred trials and several years’ delay, it does tend to add up.