The antibiotic Ketek (telithromycin) was approved by the FDA in April 2004. In 2005 it was prescribed over three million times in the US for respiratory infections -- sinusitis, bronchitis, and non-severe pneumonia -- and grossed nearly $200 million for its manufacturer, Sanofi-Aventis.
Yet the drug flunks the basic legal requirements for FDA approval: It is not safe and has never been proven effective.
The catalog of problems with Ketek is eye-popping. To name just five:
- A single therapeutic dose can kill.
- Ketek’s safety trial was riddled with fraud and FDA concealed these problems from the 2003 Advisory Committee.
- The FDA management pressured the lead safety reviewer to change his negative conclusions about Ketek.
- The drug has never been shown to work as well as a sugar pill.
- FDA management, including then-Commissioner Andrew von Eshenbach, threatened scientists who sought to tell the truth about Ketek.
The FDA management not only approved Ketek over the recommendations of its own review team, it permitted the drug-maker (then known as Aventis) to study the drug on infants as young as six-months old, despite mounting evidence that Ketek caused liver failure, blurred vision and stupors.
"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, Deputy Director of the FDA’s Division of Drug Risk Evaluation, wrote in an internal memorandum. Yet that’s precisely what FDA did.
Senate Finance Committee Chairman Charles Grassley (R-IA) called the FDA “the great facilitator, giving the drug makers what they want.”
Mounting congressional and media scrutiny about Ketek in 2006, prompted by whistleblowers, put the FDA brass on its heels. Rather than conduct a global review of the drug’s safety and efficacy, as recommended by Dr. David Ross, the former lead safety officer on Ketek, FDA management responded with a damage control strategy of obfuscation and intimidation. To create the impression that it was discharging its regulatory duty, the FDA first slapped a feckless warning label on the drug. To silence conscientious scientists, then-Acting Commissioner von Eshenbach threatened to fire safety officers who didn’t fall in line.
But all the king’s horses couldn’t put Humpty together again. In December 2006, another FDA Advisory Committee recommended repealing the approval of Ketek for bronchitis and sinusitis. In February 2007, one day before a searing Congressional hearing into the approval of Ketek, the FDA announced it was adopting these recommendations
The Ketek story sadly brings to mind the alarm sounded before the Senate Finance Committee in 2004 by Dr. David Graham, a top FDA safety official and Vioxx whistleblower, that “the FDA as currently configured is incapable of protecting America against another” drug debacle.