Updated June, 2007: At the American Diabetes Association’s annual meeting in Chicago, experts on Avandia debated recent findings about the drug from a study published in the New England Journal of Medicine.
The findings show that Avandia users have a 43% increased risk for heart attacks and a 64% rise in the risk of death from heart attacks.
Steven Nissen, the author of the study, defended his work at the conference. He said that he would rather cause alarm to patients than to “keep the scientific community in the dark”.
Nissen’s study has been criticized because it is based on pooled data from 42 trials including 28,000 patients. Some experts wonder if a study not designed to investigate heart attacks can come to these conclusions. Nissen said links between heart attacks and Avandia were ignored because the FDA was in a rush to approve the drug.
Phillip Home, who is the lead investigator in another Avandia study claims that Nissen’s study “doesn’t answer a question, it asks a question”. Home’s study, paid for by GlaxoSmithKline, shows that Avandia should have a role in the glucose-lowering armory, but heart attacks from the drug cannot be ruled out.
Because of the findings from Nissen’s study, there have been black box warnings added to Avandia’s labels. Some experts disagree with Nissen’s publication of the study because the findings have not been confirmed with randomized prospective trials.