I wrote this piece in the Guardian on clinical trial results being withheld, and the staggering denialism from diverse players including industry, the Royal Colleges, the MHRA, David Cameron, and more. This denialism has slowed progress on the issue, and cost lives. It’s my view, frankly, that people should be sacked – and presidents dismissed – over the appalling ESHLSG debacle, which gave false reassurance on vitally important matters of patient safety. The public, quite reasonably, expect better of medical leaders, especially when technical matters are entrusted to their care. Perhaps I’m wrong. In any case: the tide has turned, the public are watching, the professions are finally fully on side. We must celebrate that and move forward: now is the time to act. Here is a link to my piece, and here is the final two paragraphs.
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. Even if it passes, this will do nothing to improve the evidence base for the decisions made in clinics around the world today. The overwhelming majority of treatments prescribed by doctors right now – the everyday drugs for blood pressure, cholesterol, ulcers and more that are taken by millions – all came on the market over the past two decades, not the past seven days. That is the era of evidence that patients need.
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 an unprecedented opportunity for change. Anyone undermining the case for transparency will find themselves on the wrong side of patients and the wrong side of history. Medicine relies on evidence: future generations will look back on us tolerating withheld results in the same way we look back on medieval blood-letting.