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GSK criticised over salmeterol study reporting

Reuters report that an American consumer group, Public Citizen, have accused GlaxoSmithKline (GSK) of manipulating data from the Serevent Multicentre Asthma Research Trial (SMART).

The SMART study was a 28 week study initiated in 1996. It found that there was an increased risk of asthma-related death in the Salmeterol arm of the study compared to the control arm according to interim results presented to the Food and Drugs Administration (FDA) in 2003. The full paper has never been published although it is worth noting that many of the patients in the Salmeterol arm of the study were not prescribed steroid inhalers.

Public Citizen have accused GSK of including post-study data relating to adverse events in data submitted to the FDA with the effect of misleading the FDA.

Action: Prescribers need to be aware of this as patients may ask questions about their asthma treatment. UK patients can be re-assured that the trial in America does not mirror UK practice; most patients in the UK are prescribed a steroid inhaler for their asthma.