In a puzzling turn of events this week, an F.D.A. panel voted 20-12 to leave Avandia, from GlaxoSmithKline, on the market but with restrictions because of heart attack risks.
Avandia was once the biggest-selling diabetes medicine in the world until a study by Dr. Steven Nissen of the Cleveland Clinic found that it increased the risk of heart attacks.
This news despite a recent editorial in the Journal of the American Medical Association that concluded there is little reason that patients should ever be given Avandia, since a similar medicine, Actos, made by Takeda, works just as well but appears to involve fewer risks.
Making this decision even stranger, F.D.A. drug safety expert Dr. David Graham even co-wrote a study using records of over 227,000 patients that found Avandia increases risk of stroke, heart attack and death compared to Actos.
So what does this mean for the litigation? Time will tell. But, as the New York Times has so aptly stated, “the most troubling aspect of the Avandia saga is evidence — from internal company documents and investigations by a Senate committee and an F.D.A. investigator — that Glaxo sought to hide emerging indications of Avandia’s heart risks.”
We know that Glaxo failed to report the results of a 1999 study that showed Avandia might be riskier for the heart than a competing drug. There’s even an internal e-mail that reads, “these data should not see the light of day.”
Thankfully, the data did see the light of day, and those who were injured or who lost a loved one will have their day in court.
