GSK preaches Avandia safety to docs, forgoes new DTC
Reps for the drug marketer are focusing on A Diabetes Outcome Progression Trial (ADOPT). “We are reassuring physicians about the safety data we have, particularly looking at ADOPT,” a GSK spokeswoman told The Wall Street Journal.
Last week Cleveland Clinic cardiologist Steven Nissen, writing in The New England Journal of Medicine, reported on an analysis he did that showed patients taking the drug have a 43% greater risk of heart attack than those using other diabetes drugs or no medication. GSK disagreed, saying other data on Avandia, including ADOPT data, show the drug increased heart attack risk but that the difference didn’t achieve statistical significance, and that it told the FDA about it last year.
GSK's CEO also took up the cause last week. The Associated Press reported that Jean-Pierre Garnier acknowledged at a company shareholders meeting last Wednesday that sales of Avandia could fall and that it’s too early to predict whether the drug will be the target of product liability lawsuits but said, “We expect that once the complete data set on Avandia becomes available, our product will be vindicated."
Nevertheless, some analysts have predicted Avandia sales could be cut in half, especially considering the sharp drop in GSK’s stock price that followed the NEJM analysis.
While the spokeswoman said the company isn’t planning consumer ads to defuse the Avandia situation, it won’t rule them out, either. “At the moment, there is an information vacuum, and GSK may need to step into the void,” she told the Journal.
Ads for Avandia have not appeared on US television in the past year, due to what the paper called a “short break” that happened to be in effect when the safety concerns broke but was unrelated.
Recent ads in consumer magazines and medical journals have touted Avandia’s effectiveness. The company at one time also touted results of studies on the drug’s potential cardiovascular benefits, including one that showed Avandia might improve markers tied to cardiovascular problems. But that ended after a GSK analysis turned up a finding similar to Dr. Nissen’s. GSK says stronger evidence favoring Avandia’s safety outweighs it, according to the WSJ.
Since last year, the Avandia label has reflected warning language saying patients with heart failure who took Avandia had a higher risk of cardiovascular events. But the GSK analysis showing potential heart attack risk hasn’t been placed in the US label.
Avandia was approved in 1999 for treating Type 2 diabetes, which affects about 18 to 20 million Americans. GSK’s Avandia/Avandamet franchise had global sales of $3.2 billion for 2006. An FDA panel is due to meet to examine safety data on Avandia, following the NEJM study.