GSK drug trials: "effectively manage the dissemination of these data in order to minimise any potential negative impact".

Drugs firms face new laws on test results | # Martin Hodgson and Nicholas Watt
# The Guardian, | # Thursday March 6 2008
...
The health minister Dawn Primarolo will tell MPs that new legislation will be introduced by the end of the year to ensure drugs companies pass on results of clinical trials as soon as the alarm is raised about one of their medicines.

The government is to intervene after a four-year investigation by the drug regulatory body into the way GSK withheld the full results of their trials of the antidepressant Seroxat on children.

The trial data, which was finally handed to the Medicines and Healthcare Regulatory Authority (MHRA) in May 2003, identified two problems of which the company had been aware as early as 1998:

· A higher risk of suicidal behaviour among under 18s using Seroxat rather than a placebo.

· Seroxat was ineffective in dealing with depressive illness among under 18s. ...
...
A leaked internal document from GSK, dated to 1998, said the company would have to "effectively manage the dissemination of these data in order to minimise any potential negative impact".

In the United States, GSK was sued by the New York state attorney general, Eliot Spitzer, and settled for $2.5m (£1.25m) and an agreement to publish all its trial results - negative or positive - on a publicly available database. ...