It's a scandal drug trial results are still being withheld | Ben Goldacre | Comment is free | The Guardian
abernard102@gmail.com 2014-01-07
Summary:
The medical profession, until recently, has been supine. In 2012 the medical royal colleges, societies and even the Department of Health signed up to a bizarre set of documents – apparently orchestrated by industry – claiming there is a "robust regulatory framework" ensuring access to trial results. Not only does this give false reassurance on a vitally important matter of public safety, but the signatories refused to answer even the simplest questions about how they came to sign such peculiar statements. Now, all that has changed. Some 130 patient groups, representing more than 100 million patients, have signed up to All Trials, a campaign I co-founded with the BMJ and other groups a year ago. Others supporting the campaign include Nice, the Medical Research Council and GlaxoSmithKline one of the biggest drug companies in the world. The final frontier is delay and denialism at the Medicines and Healthcare Products Regulatory Agency, the Department of Health and the government. David Cameron, when asked about missing trial results and Tamiflu, at prime minister's questions, explained that he took this problem seriously, and suggested new EU legislation will fix it. This is untrue. New EU legislation – which the industry have been lobbying desperately against – only requires better sharing for trials starting after 2014 ... Government should ride the wave we have created, and act. There has been more progress on trials transparency in the past 12 months than in the past 25 years. Proposals from industry and regulators are riddled with loopholes so huge they exempt the vast majority of trials on the medicines we use today: but these loopholes are finally being called out.The net is tightening for those who belittle this problem, or pretend it has been fixed, and it's almost painful to see how easy it was for patients and doctors to have such an impact. We should have acted sooner, but we have
Link:
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