BioCentury
ARTICLE | Politics, Policy & Law

Political defibrillator

May 28, 2007 7:00 AM UTC

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. ...