Glaxo says drug is safe, despite study
Standing behind an incomplete study, GlaxoSmithKline said its Avandia drug does not pose threat
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One day before a Congressional hearing to evaluate the safety of GlaxoSmithKline’s drug Avandia, the New England Journal of Medicine released early findings of a study called “RECORD,” which will not be finished until 2008.
The RECORD study is funded by Glaxo, and according to the Journal, it does not provide enough data to show whether Avandia is associated with a higher rate of heart attacks. The article comes in the midst of Cleveland Clinic cardiologist Steven Nissen’s research, also printed in the Journal, which tied the drug to a higher risk of heart attacks.
Specifically, the study followed 4,447 people with Type 2 diabetes for an average of 3.75 years. In the Avandia group 217 people died of cardiovascular causes, and in the non-Avandia group, 202 died from the same.
Despite the study being incomplete and the Journal’s analysis saying the study was inconclusive, Glaxo continued to suggest the drug is safe.
“Patients and physicians should find these data reassuring,” Moncef Slaui, the head of research and development at Glaxo, said in a statement.
Glaxo has blitzed newspapers across America with full page ads printing a letter from its chief medical officer, Dr. Ronald Krall. In the letter, Krall said “GlaxoSmithKline stands firmly behind Avandia.”
Source: Jeanne Whalen and Anna Wilde Mathews, “Analysis of Avandia Finds No Increased Risk of Death,” Wall Street Journal, June 6, 2007.

