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Published on FierceBiotech (http://www.fiercebiotech.com)

GSK fights claim it manipulated asthma trial data

By admin
Created Oct 6 2005 - 8:01pm

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is sold with a "black box" warning outlining the increased risk of death, but Public Citizen says the drug should be withdrawn.

- read this report [1] from Newsday for more


Source URL:
http://www.fiercebiotech.com/story/gsk-fights-claim-it-manipulated-asthma-trial-data/2005-10-07