The tug of war between regulators and drug developers over clinical trial data has been escalating in the UK. Now the government will require developers to turn over data after GlaxoSmithKline was accused of dragging its feet on releasing data indicating that its antidepressant Seroxat is linked to an elevated risk of suicide among teens.
Critics have long contended that Big Pharma companies are notoriously slow about releasing data that could raise concerns about therapies. British authorities say that a tightening of the laws should make that impossible.
Glaxo, meanwhile, has vigorously denied acting improperly over the release of Seroxat data. The suicide risk was only evident after all the trial data was reviewed collectively, says Glaxo, rather than one trial at a time. And once it knew about the danger, adds Glaxo, the company alerted regulators around the world.
- read the article in the Wall Street Journal
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