GlaxoSmithKline has come out swinging in self-defense. The drugmaker issued a 30-page statement that vociferously denies that it conceals any safety information on the embattled drug Avandia or that it disregarded the needs of patients. And it stepped up its backing for the diabetes med, saying that a recent Senate report didn't present an accurate view of the drug.
A U.S. Senate committee last weekend released the report from its investigation of Avandia, its safety, and GSK's handling of the problematic data that first hit public view in 2007. The report was sharply critical of GSK, saying the company bullied scientists and disregarded internal concerns about the safety of the drug, which some studies had linked to increased risks of heart attack and stroke.
At the time, GSK denied the overall allegations, saying that the Senate investigators had misrepresented its conduct and the safety data on Avandia. Now, it's attacking the specifics of the report, calling out "glaring omissions" and "errors of fact ... and inference," according to a company statement.
"A fair examination of the company's record will show that GSK has been diligent in its efforts to thoroughly study the safety and effectiveness of [Avandia]," the statement says, "and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways." For copious detail, check out the white paper itself. And happy reading.
- read the GSK release
- check out the company's White Paper
- see the Bizjournals story
- get more from Reuters