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Drug firms warned to publish trial data after safety fears

Colin Brown,Jeremy Laurance
Thursday 11 November 2004 01:00 GMT
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Drug companies have been warned by the Government's drug regulator to publish the results of all clinical trials of new medicines following allegations that vital safety data has been withheld putting patients at risk.

Drug companies have been warned by the Government's drug regulator to publish the results of all clinical trials of new medicines following allegations that vital safety data has been withheld putting patients at risk.

The Medicines and Healthcare Products Regulatory Agency (MHRA) told companies it is "disappointed" by their failure to co-operate. The chief executive of the MHRA says in a letter to the Association of the British Pharmaceutical Industry, a draft copy of which has been seen by The Independent: "The public expects the industry to operate in a more transparent way... The MHRA would be grateful for your urgent views on what steps you are taking."

This follows allegations that drug companies have selectively published trial data to get new products on to the market and has concealed alarming findings about existing products.

GlaxoSmithKline was accused last year of suppressing evidence that its antidepressant drug, Seroxat, increased suicidal thoughts in children. The MHRA has banned its use on children. This month the US company, Merck and Co, was accused of withholding results about its arthritis painkiller Vioxx, which was withdrawn in September after evidence it increased the risk of heart attacks in some patients.

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