The committee unearthed internal e-mails showing that GlaxoSmithKline attempted to downplay scientific findings about the safety of Avandia as far back as 2000. It also found Avandia was part of the drug manufacturer's “ghostwriting campaign,” a practice by which drug companies initiate authorship of articles that are then marketed to medical journals for publication.
Baucus and Grassley said they were sharing these documents with the FDA just as the agency convenes an advisory board meeting this week to examine the health risks associated with Avandia. “Information is the most important tool the FDA has to protect American consumers, and the documents we uncovered in our investigation will help arm the FDA with the best information possible as it evaluates Avandia's safety,” Baucus said in a written statement.
Responding to this latest probe, GlaxoSmithKline in a written statement called the Finance panel's investigation “incomplete and misleading.” The documents do not offer new clinically relevant scientific information, “and do not provide the full extent of GSK's studies and evaluation of Avandia. GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website,” the drug manufacturer stated.
A report issued by the Senate Finance leaders this year said that GlaxoSmithKline knew of possible heart attack risks tied to Avandia years before such evidence became public.