New News or Not So New News Concerning Avandia?

It appears that the U.S. Food and Drug Administration is taking steps that may end up in removing a popular Type II Diabetes drug, Avandia, from the market. In a safety announcement issued on February 22, 2010, the FDA reported that it is continuing to review data and various studies on the drug rosiglitazone, including the RECORD study. RECORD is the acronym for Rosaglitizone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes. The results of RECORD were released in August of 2009 in a medical journal. The FDA’s safety announcement came on the heels of the recent U.S. Senate Finance Committee report which detailed the committee’s findings, including a possible link between the drug and an increased risk in heart attacks. Specifically, the Finance Committee found:

…the reviewed evidence suggests that GSK [GlaxoSmithKline] knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives 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.

Such strong language by the Senate Finance Committee likely has trial lawyers salivating over the sheer number of potential products cases that could be in the pipeline if indeed Avandia is removed from the market. Considering that Avandia sales were approximated at $2.6 billion for the year 2006, there may be potential litigation looming against GlaxoSmithKline.

However, the Senate Committee’s report is NOT news. That is at least the opinion of the American Association of Clinical Endocrinologists (AACE). Dr. Alan Garber, editor of the AACE Patient Safety Exchange, released a statement concerning the “rash of headlines” that resulted after the Senate Committee report was apparently leaked to the New York Times. In his statement, Dr. Garber provided insight on the various studies and then concluded that the “news” about Avandia was in fact “. . . old news, quite old indeed. ” Where does this leave us? Good question. However, it appears that the RECORD study concluded that Avandia did not place its users at an increased risk of death or hospitalization for cardiovascular disease. The more pertinent question may be whether use of the drug places someone at an increased risk for developing cardiovascular disease or a heart attack. As with all studies, there are sometimes more questions or concerns that are raised about the study itself. As such, the FDA is taking a prudent approach in continuing to examine the various studies including the data compiled by the RECORD study before it takes action, if any, this summer.