The circumstances surrounding the publication by the New England Journal of Medicine of a meta-analysis of safety data from studies of Avandia rosiglitazone and an accompanying commentary suggest that FDA critics on Capitol Hill have collaborated with whistleblowers in the agency and pharmaceutical industry critics in academia to create a controversy around Avandia safety in order to advance a political agenda.
Alarming headlines about Avandia last week served as a political defibrillator, shocking new life into congressional efforts to separate the assessment of drug efficacy and safety just weeks after they were defeated in the Senate and as the House Energy and Commerce Committee is set to begin debate on drug safety legislation.
In this context, it is largely irrelevant that the articles have contributed little to the scientific understanding of the drug's risks and benefits (see "Deconstructing Data," A6).
In remarks on the floor of Congress and in press releases, Sen. Chuck Grassley (R-Iowa), Rep. Henry Waxman (D-Calif.) and several of their colleagues have portrayed Avandia as the quintessential "what did they know and when did they know it" Washington scandal, complete with a maverick outsider who exposes wrong-doers and alerts congressional guardians of the public health.
The core contention is that FDA and Avandia's manufacturer, GlaxoSmithKline plc (LSE:GSK; GSK, London, U.K.), suppressed and failed to act on information about serious safety problems caused by Avandia.
Avandia, a peroxisome-proliferator-activated receptor gamma (PPAR gamma) agonist, is widely used as an insulin sensitizer to treat Type II diabetes. It is marketed as monotherapy and in combinations with metformin (Avandamet) and glimepride (Avandaryl).
If it has been hiding information, GSK