Nothing Has Changed at the FDA Since the Vioxx Debacle

If the headline above startles you, it should, considering those were the very same sentiments voiced yesterday by Dr. David Graham to the House Subcommittee on Oversight and Investigations, investigating the FDA's seeming inability to approve newer, safer drugs and provide better post-marketing monitoring.

The meeting came one day after the FDA finally announced major labeling changes to Ketek, a deadly antibiotic whose very debatable safety is defended as legitimate by Sanofi-Aventis, even though one often-cited study includes fabricated data. Now, Ketek is only approved to treat pneumonia, and not bronchitis or sinus problems.

By the way, one doctor who once worked for the FDA's Center for Drug Evaluation and Research (CDER) told the panel he had warned the agency about the life-threatening effects of Ketek to a patient's liver but his superiors had forced him to tone down his criticisms, prior to the drug's approval.

Unfortunately, the agency's Center for Drug Evaluation and Research (CDER) still treats the pharmaceutical industry as if it were the FDA's main client, Graham says. So there's no more reason today than two years ago to believe the FDA will ever get drug safety right.

Your best and safest bet: Taking ownership of your own health.

USA Today February 13, 2007

USA Today February 12, 2007