Glaxo Fails To Learn Lesson of Avandia

Source: Forbes.com

Disclose, disclose, disclose. And definitely don't leave out key facts when you publish your clinical trial.

Matthew Herper, 06.05.09

Today, GlaxoSmithKline is unveiling results of a large clinical trial it says exonerates its Avandia diabetes pill of the charge that it raises the risk of heart attack.

But the scientific paper detailing the results is missing a key fact: 40% of patients analyzed in the study were not taking Avandia at the study's end.

The 4,447-patient study, called RECORD, shows no difference in the rates at which patients were hospitalized for or killed by heart disease whether they were on a drug combination that contained Avandia or not. The study is being published in The Lancet and presented at the annual meeting of the American Diabetes Association in New Orleans.

That would seem to conflict with the headline-grabbing analysis published on May 21, 2007 by Steven Nissen of the Cleveland Clinic, which indicated, based on a pooled analysis of Glaxo's data, that patients who took Avandia were 43% more likely to have heart attacks or strokes


FULL ARTICLE HERE


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