Lead Author of Upcoming FDA Study on Avandia Says Drug Should be Banned
FDA scientist Dr. David Graham, the lead author of a huge study on Avandia involving over 227,571 Medicare patients from 2006-2009, says the popular Type-2 diabetes mediation Avandia should be banned due to a high risk of heart problems, stroke, and deaths. As many as 100,000 injuries and deaths have been linked to Avandia since its release in 1999. On Monday, June 28, 2010, editors at the Journal of the American Medical Association rushed to release the study results online so that the information could be widely disseminated prior to the formal FDA hearing on July 13-14th.
Study findings revealed that Avandia patients were 27% more likely to suffer strokes, 25% more likely to develop heart failure, and 14% more likely to die compared to patients on the rival drug Actos. The findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart failure, stroke, or sudden death would occur that could have been avoided if the patient had taken Actos rather than Avandia.
“The evidence is overwhelming,” said Dr. Graham. “There is not a single study where those two drugs are compared where Avandia doesn’t look worse than Actos. How many studies do you have to do before you come to your senses.”
Avandia has been under fire since May of 2007 when the FDA issued a Safety Alert regarding Avandia indicating a “potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” In June of 2007, the New England Journal of Medicine published a very disturbing medical study which showed patients taking Avandia substantially increased their risk for serious heart problems and heart attacks by 43% and risk of death from heart disease by up to 64%. Shortly thereafter, the FDA issued a “Black Box Warning” – the most serious warning – in response to the Journal’s report. However, the FDA did not require the drug be recalled nor did GlaxoSmithKline voluntarily recall the drug.