Drugs law to be tightened as Seroxat firm is rebuked
Ministers promised to strengthen laws to protect patients after a drugs company was criticised for withholding information about clinical trials showing links between its anti-depressant drug and possible suicides among teenagers.
Alfred and Stephanie Gatchell, from Newhaven, were among the parents who blamed the drug produced by GlaxoSmithKline for the death of their daughter, Sharise, in 2003.
The Medicines and Healthcare Products Regulatory Agency said it remained concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat. But no one from the company will face criminal charges as government prosecutors have advised there is little chance of a conviction.
The promise of tougher laws came after the MHRA announced results of an inquiry begun in 2003 when it first became aware of clinical-trials data from the company showing a suicide risk for under-18s taking Seroxat. Dawn Primarolo, the Public Health minister, told MPs: "Companies that conduct clinical trials should not compromise people's health by withholding information."
Professor Kent Woods, head of the MHRA, said tightening the law should be unnecessary "in an industry which relies so heavily on public trust and aspires to high ethical standards... However, that moral responsibility now needs to be insisted upon by the unambiguous force of law."
GSK has rejected claims it improperly withheld drug-trial data. Dr Alastair Benbow, medical director for GSK Europe, said: "We firmly believe we acted properly and responsibly in first carrying out this clinical-trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18."
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