Brits pledge law change after GSK probe

GlaxoSmithKline is off the hook in a U.K. investigation of its withholding data on the antidepressant Seroxat, sold as Paxil in the U.S. The four-year probe sought to determine whether Glaxo acted illegally when it waited till May 2003 to tell U.K. regulators that children using Seroxat had a higher risk of suicidal behavior [1]and that it was ineffective at treating depression in those under 18. Allegedly, the company knew about those problems with the med from 1998.

Well, the British government will say that GSK should have divulged the info earlier, but the company won't face any criminal charges because the laws governing trial data aren't clear. GSK has always denied that it withheld the info improperly because the med wasn't approved or marketed for use in kids. In the U.S., the company was sued by then-New York Attorney General Eliot Spitzer and settled for $2.5 million; the deal included an agreement to publish all its trial results on a public database.

The U.K. investigation may have lasting effects on pharma overall, though. According to The Guardian, Health Minister Dawn Primarlo plans to introduce legislation that would require all drug makers to reveal all clinical trial data as soon as red flags arise. "This investigation has revealed important weaknesses in the drug safety legislation," U.K. chief regulator Kent Woods told the BBC, saying that drug firms nevertheless have an "ethical responsibility" to reveal adverse data.

- here's GSK's release [2]
- see the story [3] in the Guardian
- check out the Telegraph's article [4]
- read the MarketWatch take [5] on the probe

Related Articles:
UK patients sue for Paxil withdrawal. Report [6]
Study highlights link between Paxil and suicide. Report [1]
Glaxo to let Mylan make generic Paxil. Report [7]