Docs Saying No to Avandia Before FDA Vote
As the US Food and Drug Administration conducts safety hearings on GlaxoSmithKline’s diabetes drug Avandia, many doctors are choosing on their own to discontinue writing prescriptions for the drug, according to a news report from ABC News. Many are changing patients to Actos, a similar product that has fewer risks.
The Senate Finance Committee released a report this week that GlaxoSmithKline withheld important safety data on Avandia for more than a decade. The drug, generically known as rosiglitazone, was approved in 1999 to treat type 2 diabetes, but according to the committee report, internal emails from GSK executives downplayed the negative scientific findings from clinical trials.
The documents highlight a 1999 study, referred to as Study 175, which compared Avandia to Actos and found both drugs performed equally well to lower blood sugar, but Avandia had more cardiovascular side effects. Internal GSK emails suggest that executives never wanted the findings “to see the light of day.”
"It's just not morally or ethically acceptable for companies to withhold data," says Dr. Steve Nissen, chair of Cardiovascular Medicine at the Cleveland Clinic and author of the original RECORD study, which raised public concern over Avandia's safety. That analysis found that those on Avandia had a 43% higher risk of heart attack and a 64% higher risk of dying from heart disease than its competitive products.
ABC News reports that doctors are reporting a reduction in prescribing or completely switching patients over to Actos. Dr. Andrew Carroll, a family physician in Arizona said, “Based on prior studies I had read, I stopped prescribing Avandia about two years ago, and have been sticking with Actos.” Dr. John Sutherland at Northeast Iowa Medical Education Foundation says that he has a few remaining patients on the drug, but are slowly shifting all of his at-risk patients over to Actos.
Though the drug has lost more than half of its sales since the 2007 study, it still has generated more than $1 billion in revenue and was prescribed to 2.6 million Americans in 2009.