Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings.

FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings

However, the CDER leadership refused to accept the conclusion of regulators around the world and its own advisory committee that Avandia is hazardous.

FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings

In Congressional testimony, CDER officials acknowledged that FDA statisticians had confirmed our findings, reporting a 40% increase in the risk of heart attack.

FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings