GSK fights claim it manipulated asthma trial data

GlaxoSmithKline is fighting claims that it cooked the books on trial data for the asthma drug Serevent. Public Citizen's Health Research Group asserted in a letter to The Lancet that researchers added six-month follow-up data to a 28-week safety study to help blur the risks associated with the therapy. During the 28-week trial, 13 patients taking Serevent died, four times as many deaths as occurred among patients taking a placebo. Six months later, a total of 15 Serevent patients had died, two-and-a-half times the placebo mortality rate. GSK says that the FDA subsequently asked the drug developer to submit data from the 28-week period and denied that it was trying to fudge safety issues. Serevent is sold with a "black box" warning outlining the increased risk of death, but Public Citizen says the drug should be withdrawn.

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