The ongoing controversy over the Avandia diabetes pill - specifically, whether GlaxoSmithKline properly disclosed clinical trial data and its related marketing efforts - has prompted the US Department of Justice to issue a subpoena to the drugmaker. At the same time, several state attorneys general offices have issued Civil Investigative Demands.
The investigations were disclosed in the third-quarter earnings statement issued today, which includes this brief comment from Glaxo: "These enquiries are at an early-stage, and GSK is cooperating with these offices." Meanwhile, Glaxo also received a subpoena from the US Attorney in Brooklyn, New York, concerning "sales and marketing practices for three HIV products, as well as educational programs, grants or payments to physicians regarding any drug used to treat HIV-infected adults." The HIV meds were not named, although Glaxo recently formed an HIV joint venture called ViiV Healthcare with Pfizer.
The investigations into Avandia are hardly surprising. A US Senate Finance Committee probe (read that here) released earlier this year criticized Glaxo for failing to warn patients years ago that Avandia was potentially deadly. Glaxo execs "attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” according to the report. Glaxo has vigorously disputed the conclusions. After months of debate and a dramatic FDA advisory committee meeting this past summer, the agency issued tighter restrictions on Avandia usage.