FDA Management Escapes Culpability for Avandia Debacle

In the face of overwhelming evidence that the diabetes drug Avandia causes heart attacks, the lead-footed FDA finally removed the dangerous drug from most of the U.S. market while European health officials totally removed it from the market. By leaving it on the market as a diabetes drug of last resort in the U.S. the FDA was seeking to throw GlaxoSmithKline a dog bone for their future legal liability cases. Escaping public attention is that fact that the last FDA management team was criminally negligent in allowing Avandia on the market without a black box warning.

The record shows that the FDA knew full well the drug caused heart attacks before it was ever put on the market. On June 6, 2007 the New York Times revealed a stunning event that occurred in March of 2006 wherein FDA safety supervisor Dr. Rosemary Johann-Liang approved a black box warning on Avandia to warn about the risk for congestive heart failure. Former FDA commissioner, Andrew von Eschenbach and his management team ordered her to retract her approval of the warning. She was then stripped of her power to make such warnings and removed from supervision of the safety of Avandia.

The FDA said nothing as the sales of Avandia skyrocketed to 3.2 billion. It was only after the private sector started publishing emerging risk data that Congress became alarmed and scheduled FDA executives for a hearing. Only at that time did the FDA begin to move and take damage control steps. Not damage control for public safety, but damage control for their own rear ends. So the drug stayed on the market for three more years, weakening the legal liability case against GlaxoSmithKline, giving Andrew von Eschenbach time to get out of Dodge, and killing numerous Americans.

In a normal world this is called manslaughter. In the world of Big Pharma and the FDA this is business as usual. Until criminally negligent Big Pharma executives are put behind bars, and when appropriate the co-conspiring FDA management, then U.S. citizens will be seriously injured and U.S. taxpayers will foot Big Pharma’s legal defense with increased costs for drugs.