Friday, May 25, 2007
Article in the Wall Street Journal -- Glaxo Courts Doctor Support of Avandia: No Plans Currently Set To Run Consumer Ads To Defend Drug's Safety, by Jeanne Whalen and Anna Wilde Mathews. Here's an excerpt:
GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety, but isn't currently planning a similar ad campaign for consumers.
In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman.
Monday, the New England Journal of Medicine released an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. Glaxo disagrees with the finding, which it says is contradicted by data the company considers stronger, including ADOPT data.
Congressional investigators are examining the Food and Drug Administration's and the company's handling of the drug. Yesterday, Republican Sen. Charles Grassley of Iowa said that the FDA's division of drug-risk evaluation had recommended a tough "black box" warning about heart-attack risk for the label of Avandia, which hasn't been added. He and Senate Finance Committee Chairman Max Baucus, a Montana Democrat, introduced a bill that would grant researchers access to Medicare data on medical treatments.