The week of 12-16 July saw an FDA Advisory Panel meet to decide the fate of an important drug. Along the way, the FDA charted new territory in using drug comparisons to judge safety, amidst external allegations of corporate malfeasance and patient harm.
Avandia, or rosiglitazone, is one of a new class of anti-diabetes drugs approved for marketing by the FDA in 1999. It, and its competitor, Actos (pioglitazone), are thiazolidinediones (TZD’s), a class of drugs that act to decrease insulin resistance. A third TZD, troglitazone, was withdrawn after studies showed a 1:20,000 incidence of hepatitis and potential liver failure.
Avandia was a clear market success, with sales peaking at $2.5B in 2006, the year prior to the first research “shot across the bow” regarding patient safety.
Among scientists, the mid-July review capped a rising level of concern. Among the public, a tide of safety concern had been rising for several years, flowing from the scientific community into the legal and political arena.