FDA Paralyzed: Who Will Protect Us?

A few weeks ago, I wrote about how the FDA approved Ketek based on foreign trial data. I raised the suspicion that the FDA was eager -- perhaps too eager it turns out -- to get the antibiotic approved in order to have an effective drug to add to America's anti-bioterrorism stockpile (see "Celsius 3014: Ketek, Drug Safety, & Bioterrorism").

Now we have to learn from an FDA memorandum leaked to the New York Times that a Food and Drug Administration official called in May for a Sanofi-Aventis to halt clinical trials of Ketek in children because the drug could be deadly.

"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the Office of Drug Safety at the agency, wrote in one of the memorandums.

"The report also said that by April, the agency had reports of 110 cases of liver problems associated with Ketek, and that the rate of acute liver failure connected to the drug was about four times the rate of such events seen in other antibiotics."

Not until the story was published in the New York Times yesterday (see "Halt Is Urged for Trials of Antibiotic in Children") did the company call a halt to the trial -- and even then Sanofi-Aventis said the FDA did not request the action!

Despite the company's insistence that its action was not linked to the story in the NYT the day before the trial was stopped, it's just too much of a coincidence.

In other words, it takes a story leaked to the press and for that story to actually appear in the press to stop a potentially deadly trial.

If that is the only way that FDA officials can do their jobs, then God help us, because the FDA sure can't.