Just a brief post on how gratifying it is to see the government obediently doing exactly what I told them to and announcing plans to ensure that all drug company trial data is registered and disclosed. The MHRA press release is below so that you can bathe in unmediated news.
One thing still troubles me: covering up harms from medication is tangibly evil, and eye catching; but it’s a shame that it takes this to trigger concerns, because the issue of covering up results which simply show your drug performing poorly against placebo is equally important, although less eyecatching. In fact I would say it’s more important, because it’s probably more prevalent, and has been known about for so many decades that it’s also more of an embarrassment that we’re only sorting it out now.
No trial should be done without being registered, no trial should be passed by an ethics committee without a commitment to publish, and no collaborative contract should exist between a company and an academic department – on any kind of treatment – without a clear clause in the contract stating that the researchers will have freedom to write up as they wish.
The interesting thing about epidemiology and big numbers is that it’s easy to forget what they mean. Bad data costs lives, and this piece of legislation, whilst nerdy, will probably have a greater impact on important things like death and pain than anything about foxes or tinkered health spending.
Date: 6th March 2008
Contact: Press Office 020 7084 3535 / 3564 email@example.com
Out of hours 07770 446 189
GSK investigation concludes
The MHRA has concluded its four year investigation into Glaxosmithkline and its anti-depressant drug Seroxat. The investigation focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18’s in a timely manner. The investigation was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation. It was the largest investigation of its kind in the UK, and included the scrutiny of over 1 million pages of evidence.
The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution. The legislation in force at the time was not sufficiently strong or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside its licensed indications.
GSK provided the MHRA with data from clinical trials in May 2003, confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo; and that Seroxat was ineffective in treating depressive illness in under 18’s. Acting upon this information the MHRA immediately reviewed the data and published advice to all doctors that Seroxat should not be used in under 18’s. The investigation arose from concern that GSK had held the information for some time before this and failed to disclose it.
Professor Kent Woods, MHRA Chief Executive, said: “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them. This investigation has revealed important weaknesses in the drug safety legislation in force at the time. Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues.”
NOTES TO EDITORS
1. See website homepage www.mhra.gov.uk to download full report and related
Next up, I’d like the government to buy into my other unloopy idea (not really just mine) of randomising every single treatment episode in the NHS, wherever there is genuine uncertainty about which is the better of two therapeutic options. It would answer the important questions about huge numbers of treatments in a trice, with admirable statistical power, it wouldn’t add much to the costs of running the NHS, it would be a great gift to humanity, and nobody would suffer, because we’d only be randomising between two treatments where nobody knew which of the two was better anyway.
Hopefully it’ll only take them a week or so to pop that one onto the legislative calendar.
But more importantly, back to the task in hand. Guiding blog discussion is like herding cats, but try this on, imagine you have unimaginable power….
….how would you write this new legislation to govern the pharmaceutical industry and make them hand over data?